A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection

Launched by TAKEDA · Sep 26, 2024

Nctid: NCT06615921

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D003586", "term"=>"Cytomegalovirus Infections"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D004266", "term"=>"DNA Virus Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M6791", "name"=>"Cytomegalovirus Infections", "asFound"=>"Cytomegalovirus (CMV)", "relevance"=>"HIGH"}, {"id"=>"M9643", "name"=>"Herpesviridae Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"T1720", "name"=>"Cytomegalic Inclusion Disease", "asFound"=>"Cytomegalovirus (CMV)", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M349332", "name"=>"Maribavir", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>150}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-10-14", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-12", "completionDateStruct"=>{"date"=>"2025-04-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-12-10", "studyFirstSubmitDate"=>"2024-08-23", "studyFirstSubmitQcDate"=>"2024-09-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-12-13", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-04-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Number of Participants With Viremia Clearance Before the End of Maribavir Treatment", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"CMV viremia clearance is defined as a negative Quantitative Polymerase Chain Reaction (PCR) result. A PCR result is defined as negative if CMV DNA is undetectable or below the lower limit of quantification as per local laboratory practice. Number of participants with the last CMV quantitative negative PCR result before the end of maribavir treatment will be reported."}], "secondaryOutcomes"=>[{"measure"=>"Participants Categorized Based on Demographic Characteristics", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants will be reported by their demographic characteristics (age, sex, past conditions and comorbidities)."}, {"measure"=>"Participants Categorized by Transplant-Related Characteristics", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants will be reported by transplant-related characteristics (type of transplant \\[HSCT/SOT\\]), transplant indication, donor and recipient CMV serostatus)."}, {"measure"=>"Participants Characterized by Previous CMV Infection (Medical History)", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants with prior CMV infections and clinical manifestations of CMV disease before Index CMV episode. Index CMV episode is defined as first CMV episode treated with maribavir."}, {"measure"=>"Participants Characterized by Use of Prior Anti-CMV Treatment Strategies", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants will be reported by treatments used (e.g. valganciclovir, ganciclovir, cidofovir, foscarnet or letermovir), by number and sequence of treatments/per CMV episode, by treatment strategy (e.g. prophylaxis, pre-emptive, treatment) before Index CMV episode. Index CMV episode is defined as first CMV episode treated with maribavir."}, {"measure"=>"Duration of Each Treatment With Maribavir During Index and/or Post-Index CMV Episodes", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Duration between start and end of treatment during Index and Post-index CMV episodes will be reported. Index CMV episode is defined as first CMV episode treated with maribavir. Post-index CMV episode is defined as first CMV recurrent episode after Index episode."}, {"measure"=>"Number of Repeated Treatments With Maribavir During Index and/or Post-Index CMV Episodes", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of repeated treatments with maribavir per CMV episode will be reported during index and/or post-index CMV episodes."}, {"measure"=>"Maribavir Administration by Line of Therapy During Index and/or Post-Index CMV Episodes", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants who received maribavir, as derived from the treatments sequence within a specific CMV episode, stratified by line of therapy."}, {"measure"=>"Participants With Maribavir Dose Adjustments During Index and/or Post-Index CMV Episodes", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants with maribavir dose adjustments and average dose adjustments will be reported."}, {"measure"=>"CMV Viral Load Prior to Maribavir Initiation, During Treatment With Maribavir, and After Discontinuation", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Available CMV viral loads of interest prior to maribavir initiation, during treatment with maribavir, and after discontinuation will be reported for each maribavir treatment administered."}, {"measure"=>"Reasons for Initiating and Discontinuing Maribavir Treatment During Index and/or Post-Index CMV Episodes", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants categorized by their reasons for initiating and discontinuing maribavir treatment will be reported."}, {"measure"=>"Place of Initiation of Maribavir Treatment", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants categorized by place of initiation of maribavir treatment (Home/Hospital) will be reported."}, {"measure"=>"Duration of Maribavir Treatment During Hospital In-patient Stay", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of days of maribavir treatment during hospital in-patient stay will be reported."}, {"measure"=>"Participants who Received Maribavir Monotherapy or Maribavir in Combination With Other Antivirals", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants who received maribavir as monotherapy or in combination with other antivirals such as valganciclovir, ganciclovir, letermovir, cidofovir or foscarnet will be reported."}, {"measure"=>"Participants who Received Concomitant Use of CMV-Specific IgG During Index and/or Post-Index CMV Episodes", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants who received concomitant use of CMV-specific IgG during maribavir treatment will be reported."}, {"measure"=>"Participants With Concomitant Use of Granulocyte Colony-Stimulating Factor (G-CSF)", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants who received concomitant use of G-CSF during maribavir treatment will be reported."}, {"measure"=>"Participants With Immunosuppressive Therapy Adjustments During Index and/or Post-Index CMV Episodes", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants with immunosuppressive therapy adjustments during Index and/or Post-index CMV episodes will be reported."}, {"measure"=>"Time to First CMV Viremia Clearance After Initiation of Maribavir During Index and/or Post-Index CMV Episodes", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Time to first CMV viremia clearance (first negative PCR) after initiation of maribavir will be reported. CMV viremia clearance is defined as a negative Quantitative PCR result. A PCR result is defined as negative if CMV DNA is undetectable or below the lower limit of quantification as per local laboratory practice."}, {"measure"=>"Time to First CMV Viremia Control After Initiation of Maribavir During Index and/or Post-Index CMV Episodes", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Time to first CMV viremia control after initiation of maribavir will be reported. Viremia control is defined as at least a 1 log10 decrease in CMV DNA levels in blood, serum, or plasma, assessed through PCR, from the peak viral load before initiation of maribavir treatment and peak viral load at subsequent weeks of maribavir treatment."}, {"measure"=>"Participants With CMV Viremia Control per Week After Initiation of Maribavir During Index and/or Post-Index CMV Episodes", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants with CMV viremia control per week after initiation of maribavir will be reported. Viremia control is defined as at least a 1 log10 decrease in CMV DNA levels in blood, serum, or plasma, assessed through PCR, from the peak viral load before initiation of maribavir treatment and peak viral load at subsequent weeks of maribavir treatment."}, {"measure"=>"Participants With Cumulative CMV Viremia Control at the End of Maribavir Treatment During Index and/or Post-Index CMV Episodes", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants with cumulative CMV viremia control at the end of maribavir treatment will be reported. Viremia control is defined as at least a 1 log10 decrease in CMV DNA levels in blood, serum, or plasma, assessed through PCR, from the peak viral load before initiation of maribavir treatment and peak viral load at subsequent weeks of maribavir treatment."}, {"measure"=>"Incidence of Tissue Invasive Disease During Index and/or Post-Index CMV Episodes", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Percentage of participants with tissue invasive disease during Index and/or Post-index CMV episodes will be reported."}, {"measure"=>"Time to Tissue Invasive Disease During Index and/or Post-Index CMV Episodes", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Time to event of tissue invasive disease will be reported."}, {"measure"=>"Incidence of CMV Syndrome Disease During Index and/or Post-Index CMV Episodes", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Percentage of participants with CMV syndrome disease will be reported."}, {"measure"=>"Time to CMV Syndrome Disease During Index and/or Post-Index CMV Episodes", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Time to event of CMV syndrome disease will be reported."}, {"measure"=>"Participants With Reduction or Resolution of CMV Disease/Syndrome at the End of Maribavir Treatment", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants with reduction or resolution of CMV disease/syndrome at the end of maribavir treatment will be reported."}, {"measure"=>"Time to Reduction or Resolution of CMV Disease/Syndrome After Maribavir Initiation", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Time to reduction or resolution of CMV disease/syndrome after maribavir initiation will be reported."}, {"measure"=>"Participants With Recurrent CMV Viremia (Post-Index CMV Episode)", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants with asymptomatic and symptomatic recurrent CMV viremia (Post-index CMV episode) will be reported."}, {"measure"=>"Time From Maribavir Discontinuation to Next CMV Treatment and Anti-CMV Agent Used", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Time from maribavir discontinuation to next CMV treatment and anti-CMV agent will be reported."}, {"measure"=>"Participants With Anti-CMV Detected Resistance Mutations in the Study Population", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants with detected anti-CMV resistance mutations prior to and after initiation of maribavir will be reported."}, {"measure"=>"Participants With Anti-CMV Treatment Related Adverse Events of Special Interest (AESI)", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants with Anti-CMV Treatment Related AESI will be reported. AESI will include myelosuppression (for example, leucopenia, thrombocytopenia, lymphopenia, neutropenia, etc.), nephrotoxicity and taste disturbances."}, {"measure"=>"Participants With Abnormal Laboratory Parameters Related to AESI", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants with abnormal laboratory parameters related to AESI will be reported. Laboratory parameters refer to complete blood count, glomerular filtration, etc."}, {"measure"=>"Participants With AESI Related to the Administration of Maribavir", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants with AESI related to the administration of maribavir will be reported."}, {"measure"=>"Participants With Outpatient Visit/Hospitalization Related to CMV Management", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Number of participants with outpatient visit/hospitalization related to CMV management will be reported. Participants will be categorized by type of visit (outpatient, hospitalizations/emergency department visits), primary reason for the visit, CMV-related exams/procedures."}, {"measure"=>"Length of Hospital Stay in Days for CMV-related Hospitalizations", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Length of hospital stay in days for CMV -related hospitalizations will be reported."}, {"measure"=>"Duration in Days of Critical Care against Non-critical Care", "timeFrame"=>"From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months", "description"=>"Duration in days of stay in critical care and non-critical care will be reported."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Drug Therapy"], "conditions"=>["Cytomegalovirus (CMV)"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"https://clinicaltrials.takeda.com/study-detail/23f41f1b0bb64428??page=1&idFilter=TAK-620-5010", "label"=>"To obtain more information about this study, click this link."}]}, "descriptionModule"=>{"briefSummary"=>"The main aim of this study is to check how effective the treatment with Maribavir has been to remove the CMV viruses from the blood of an adult person with CMV infection after a transplant. Other aims are to learn more about how maribavir is used in normal clinical routine, study the profiles of adults treated with maribavir, and what other treatments have been given, and describe healthcare resources used for CMV management.\n\nOnly data already available in the medical records of the participants will be reviewed and collected during this study.", "detailedDescription"=>"This study will include two main periods of retrospective data collection from medical charts: the pre-index period and the post-index period. The index date is defined as the date of initiation of maribavir dosing, as documented in the medical records. The pre-index period covers the time from the transplant date to the index event, while the post-index period starts at the index event and ends at the date of chart abstraction, death, or loss to follow-up, whichever comes first."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Participants who have been diagnosed with Post-Transplant Cytomegalovirus infection/disease in several European countries.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion criteria:\n\n* Aged greater than or equal to (\\>=) 18 years at the time of consent or start of chart abstraction in case a consent waiver will be allowed as per local regulation.\n* Received an HSCT/SOT.\n* Diagnosed with CMV infection/disease any time after the HSCT/SOT date.\n* Initiated maribavir at least 4 months before the chart abstraction date (or at time of Central Ethics Committee \\[CEC\\]/Local Ethics Committee \\[LEC\\] submission as per local regulation).\n* Participants with hospital medical chart available, who signed an informed consent form before starting any study procedures (unless waiver is allowed as per local regulation).\n\nExclusion criteria:\n\n* Participants who do not provide informed consent, where consent is required per country regulations.\n* Participants who participated to Clinical Trials investigating maribavir."}, "identificationModule"=>{"nctId"=>"NCT06615921", "briefTitle"=>"A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Takeda"}, "officialTitle"=>"A Multi-country, Multi-center, Retrospective Chart Review to Describe the Use of Maribavir and Its Effectiveness in Patients With Post-Transplant Cytomegalovirus Infection/Disease", "orgStudyIdInfo"=>{"id"=>"TAK-620-5010"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Participants With CMV Infection Refractory", "description"=>"Participants who had a CMV infection/disease that is refractory to treatment (with or without resistance). Data will be retrospectively collected from date of solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT) up to the start date of chart abstraction, death or loss to follow-up, whichever comes first. Participants will be considered as refractory if they show no change or increased viremia after at least 2 weeks of appropriately dosed antiviral therapy.", "interventionNames"=>["Other: No Intervention"]}, {"label"=>"Participants With CMV Infection Intolerant", "description"=>"Participants with CMV infection intolerant to anti-CMV treatment. Data will be retrospectively collected from date of SOT/HSCT up to the start date of chart abstraction, death or loss to follow-up, whichever comes first. Intolerant participants identified based on physician judgment.", "interventionNames"=>["Other: No Intervention"]}], "interventions"=>[{"name"=>"No Intervention", "type"=>"OTHER", "description"=>"This is a non-interventional study.", "armGroupLabels"=>["Participants With CMV Infection Intolerant", "Participants With CMV Infection Refractory"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"1090", "city"=>"Vienna", "status"=>"RECRUITING", "country"=>"Austria", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Farsad-Alexander Eskandary", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Medical University of Vienna Dept. of Nephrology and Dialysis", "geoPoint"=>{"lat"=>48.20849, "lon"=>16.37208}}, {"zip"=>"2100", "city"=>"Copenaghen", "status"=>"NOT_YET_RECRUITING", "country"=>"Denmark", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Marie Helleberg", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Copenhagen University Hospital, Rigshospitalet", "geoPoint"=>{"lat"=>55.67594, "lon"=>12.56553}}, {"zip"=>"33000", "city"=>"Bordeaux", "status"=>"NOT_YET_RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Lionel Couzi", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Groupe Hospitalier Pellegrin - CHU BORDEAUX", "geoPoint"=>{"lat"=>44.84044, "lon"=>-0.5805}}, {"zip"=>"21000", "city"=>"Dijon", "status"=>"NOT_YET_RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Claire Tinel", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Department of Nephrology, University Hospital of Dijon", "geoPoint"=>{"lat"=>47.31667, "lon"=>5.01667}}, {"zip"=>"59000", "city"=>"Lille", "status"=>"NOT_YET_RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Fanny Vuotto", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Hopital Claude Huriez CHRU Lille", "geoPoint"=>{"lat"=>50.63297, "lon"=>3.05858}}, {"zip"=>"34295", "city"=>"Montpellier", "status"=>"NOT_YET_RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Laurene Tardieu", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"CHU Montpellier", "geoPoint"=>{"lat"=>43.61092, "lon"=>3.87723}}, {"zip"=>"06000", "city"=>"Nice", "status"=>"NOT_YET_RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Clement Gosset", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"CHU De Nice Hopital Pasteur 2", "geoPoint"=>{"lat"=>43.70313, "lon"=>7.26608}}, {"zip"=>"75010", "city"=>"Paris", "status"=>"NOT_YET_RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Gillian Divard", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Hopital Saint-Louis AP-HP Pitor", "geoPoint"=>{"lat"=>48.85341, "lon"=>2.3488}}, {"zip"=>"75013", "city"=>"Paris", "status"=>"NOT_YET_RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Yanis Tamzali", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"APHP, Sorbonne University, Pitie Salpetriere Hospital", "geoPoint"=>{"lat"=>48.85341, "lon"=>2.3488}}, {"zip"=>"75015", "city"=>"Paris", "status"=>"NOT_YET_RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Dany Anglicheau", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Necker-Enfants Malades Hospital", "geoPoint"=>{"lat"=>48.85341, "lon"=>2.3488}}, {"zip"=>"67000", "city"=>"Strasbourg", "status"=>"NOT_YET_RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Sophie Caillard-Ohlmann", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Hopitaux Universitaires de Strasbourg", "geoPoint"=>{"lat"=>48.58392, "lon"=>7.74553}}, {"zip"=>"31400", "city"=>"Toulouse", "status"=>"NOT_YET_RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Nassim Kamar", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Toulouse University Hospital - Hopital de Rangueil", "geoPoint"=>{"lat"=>43.60426, "lon"=>1.44367}}, {"zip"=>"52074", "city"=>"Aachen", "status"=>"NOT_YET_RECRUITING", "country"=>"Germany", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Anja Muhlfeld", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Uniklinik RWTH Aachen", "geoPoint"=>{"lat"=>50.77664, "lon"=>6.08342}}, {"zip"=>"10117", "city"=>"Berlin", "status"=>"NOT_YET_RECRUITING", "country"=>"Germany", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Klemens Budde", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Charite, Dept of Nephrology", "geoPoint"=>{"lat"=>52.52437, "lon"=>13.41053}}, {"zip"=>"45147", "city"=>"Essen", "status"=>"NOT_YET_RECRUITING", "country"=>"Germany", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Oliver Witzke", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Clinic for Infectiology - Essen", "geoPoint"=>{"lat"=>51.45657, "lon"=>7.01228}}, {"zip"=>"17475", "city"=>"Greifswald", "status"=>"NOT_YET_RECRUITING", "country"=>"Germany", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"William Kruger", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University Hospital Greifswald", "geoPoint"=>{"lat"=>54.09311, "lon"=>13.38786}}, {"zip"=>"20246", "city"=>"Hamburg", "status"=>"NOT_YET_RECRUITING", "country"=>"Germany", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Dietlinde Janson", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Clinic for stem cell transplantation - Hamburg (UKE)", "geoPoint"=>{"lat"=>53.57532, "lon"=>10.01534}}, {"zip"=>"30625", "city"=>"Hannover", "status"=>"NOT_YET_RECRUITING", "country"=>"Germany", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Jens Tobias Gottlieb", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Hannover Medical School - Resp Medicine", "geoPoint"=>{"lat"=>52.37052, "lon"=>9.73322}}, {"zip"=>"04103", "city"=>"Leipzig", "status"=>"NOT_YET_RECRUITING", "country"=>"Germany", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Georg-Nikolaus Franke", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Uniklinik Leipzig", "geoPoint"=>{"lat"=>51.33962, "lon"=>12.37129}}, {"zip"=>"55131", "city"=>"Mainz", "status"=>"NOT_YET_RECRUITING", "country"=>"Germany", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Oliver Kriege", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Medicine Clinic of Johannes Gutenberg - Mainz university", "geoPoint"=>{"lat"=>49.98419, "lon"=>8.2791}}, {"zip"=>"80336", "city"=>"Munich", "status"=>"NOT_YET_RECRUITING", "country"=>"Germany", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Nikolaus Kneidinger", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Ludwig-Maximilians University (LMU) Hospital", "geoPoint"=>{"lat"=>48.13743, "lon"=>11.57549}}, {"zip"=>"89081", "city"=>"Ulm", "status"=>"NOT_YET_RECRUITING", "country"=>"Germany", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Elisa Sala", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University of Ulm", "geoPoint"=>{"lat"=>48.39841, "lon"=>9.99155}}, {"zip"=>"97080", "city"=>"Wurzburg", "status"=>"NOT_YET_RECRUITING", "country"=>"Germany", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Daniel Teschner", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Universitaetsklinikum Wuerzburg", "geoPoint"=>{"lat"=>49.79391, "lon"=>9.95121}}, {"zip"=>"00136", "city"=>"Roma", "status"=>"NOT_YET_RECRUITING", "country"=>"Italy", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Patrizia Chiusolo", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Policlinico Gemelli - Roma", "geoPoint"=>{"lat"=>41.89193, "lon"=>12.51133}}, {"zip"=>"3015", "city"=>"Rotterdam", "status"=>"NOT_YET_RECRUITING", "country"=>"Netherlands", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Annoek Broers", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Erasmus MC Cancer Institute", "geoPoint"=>{"lat"=>51.9225, "lon"=>4.47917}}, {"zip"=>"3584", "city"=>"Utrecht", "status"=>"NOT_YET_RECRUITING", "country"=>"Netherlands", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Marjolein Petronella Maria Hensgens", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"UMC Utrecht (Hematology)", "geoPoint"=>{"lat"=>52.09083, "lon"=>5.12222}}, {"zip"=>"11000", "city"=>"Belgrade", "status"=>"NOT_YET_RECRUITING", "country"=>"Serbia", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Milena Todorovic Balint", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University of Belgrade", "geoPoint"=>{"lat"=>44.80401, "lon"=>20.46513}}, {"zip"=>"21000", "city"=>"Novi Sad", "status"=>"NOT_YET_RECRUITING", "country"=>"Serbia", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Ivana Urosevic", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Clinical Center of Vojvodina", "geoPoint"=>{"lat"=>45.25167, "lon"=>19.83694}}, {"zip"=>"08035", "city"=>"Barcelona", "status"=>"NOT_YET_RECRUITING", "country"=>"Spain", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Ibai Los Arcos", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Hospital Universitari Vall d'Hebron", "geoPoint"=>{"lat"=>41.38879, "lon"=>2.15899}}, {"zip"=>"48903", "city"=>"Bilbao", "status"=>"NOT_YET_RECRUITING", "country"=>"Spain", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Regino Rodriguez", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Hospital de Cruces", "geoPoint"=>{"lat"=>43.26271, "lon"=>-2.92528}}, {"zip"=>"18014", "city"=>"Granada", "status"=>"NOT_YET_RECRUITING", "country"=>"Spain", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Pedro Gonzales Sierra", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Hospital Virgen de las Nieves", "geoPoint"=>{"lat"=>37.18817, "lon"=>-3.60667}}, {"zip"=>"35010", "city"=>"Las Palmas", "status"=>"NOT_YET_RECRUITING", "country"=>"Spain", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Imanol Pulido", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Hospital Dr. Negrin", "geoPoint"=>{"lat"=>28.58232, "lon"=>-16.16555}}, {"zip"=>"28041", "city"=>"Madrid", "status"=>"NOT_YET_RECRUITING", "country"=>"Spain", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Ana De Pablo", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Hospital 12 de Octubre", "geoPoint"=>{"lat"=>40.4165, "lon"=>-3.70256}}, {"zip"=>"28222", "city"=>"Madrid", "status"=>"NOT_YET_RECRUITING", "country"=>"Spain", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Rafael Duarte", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Hospital Puerta del Hierro", "geoPoint"=>{"lat"=>40.4165, "lon"=>-3.70256}}, {"zip"=>"39008", "city"=>"Santander", "status"=>"NOT_YET_RECRUITING", "country"=>"Spain", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Arancha Bermudez", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Hospital Universitario Marques de Valdecilla", "geoPoint"=>{"lat"=>43.46472, "lon"=>-3.80444}}, {"zip"=>"1205", "city"=>"Geneva", "status"=>"NOT_YET_RECRUITING", "country"=>"Switzerland", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Dionysios Neofytos", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University Hospital of Geneva", "geoPoint"=>{"lat"=>46.20222, "lon"=>6.14569}}, {"zip"=>"B15 2GW", "city"=>"Birmingham", "status"=>"NOT_YET_RECRUITING", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Adnan Sharif", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University Hospitals Birmingham", "geoPoint"=>{"lat"=>52.48142, "lon"=>-1.89983}}, {"zip"=>"CB2 0AY", "city"=>"Cambridge", "status"=>"NOT_YET_RECRUITING", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Jasvir Parmar", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Royal Papworth Hospital (Cambridge)", "geoPoint"=>{"lat"=>52.2, "lon"=>0.11667}}, {"zip"=>"NW1 2BU", "city"=>"London", "status"=>"NOT_YET_RECRUITING", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Karl Peggs", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University College Hospital London", "geoPoint"=>{"lat"=>51.50853, "lon"=>-0.12574}}, {"zip"=>"SE5 9RS", "city"=>"London", "status"=>"NOT_YET_RECRUITING", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Varun Mehra", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Kings College Hospital (London)", "geoPoint"=>{"lat"=>51.50853, "lon"=>-0.12574}}, {"zip"=>"SW3 6JJ", "city"=>"London", "status"=>"NOT_YET_RECRUITING", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Emma Nicholson", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Royal Marsden Hospital (London)", "geoPoint"=>{"lat"=>51.50853, "lon"=>-0.12574}}, {"zip"=>"M13 9WL", "city"=>"Manchester", "status"=>"NOT_YET_RECRUITING", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Muir Morton", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Manchester Royal Infirmary", "geoPoint"=>{"lat"=>53.48095, "lon"=>-2.23743}}, {"zip"=>"NE7 7DN", "city"=>"Newcastle", "status"=>"NOT_YET_RECRUITING", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Colin Wilson", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Freeman Hospital Newcastle upon Tyne", "geoPoint"=>{"lat"=>54.97328, "lon"=>-1.61396}}, {"zip"=>"NG5 1PB", "city"=>"Nottingham", "status"=>"NOT_YET_RECRUITING", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Catherine C. Byrne", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Nottingham University Hospital NHS trust (Queens Medical Centre)", "geoPoint"=>{"lat"=>52.9536, "lon"=>-1.15047}}, {"zip"=>"SO16 6YD", "city"=>"Southampton", "status"=>"NOT_YET_RECRUITING", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Site Contact", "role"=>"CONTACT"}, {"name"=>"Kim Harold Orchard", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University Hospital Southampton NHS FT", "geoPoint"=>{"lat"=>50.90395, "lon"=>-1.40428}}], "centralContacts"=>[{"name"=>"Takeda Contact", "role"=>"CONTACT", "email"=>"medinfoUS@takeda.com", "phone"=>"+1-877-825-3327"}], "overallOfficials"=>[{"name"=>"Study Director", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Takeda"}]}, "ipdSharingStatementModule"=>{"url"=>"https://vivli.org/ourmember/takeda/", "infoTypes"=>["STUDY_PROTOCOL", "SAP", "ICF", "CSR"], "ipdSharing"=>"YES", "description"=>"Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", "accessCriteria"=>"IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Takeda", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}