Nctid:
NCT06235775
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010243", "term"=>"Paralysis"}, {"id"=>"D000013494", "term"=>"Supranuclear Palsy, Progressive"}], "ancestors"=>[{"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000001480", "term"=>"Basal Ganglia Diseases"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009069", "term"=>"Movement Disorders"}, {"id"=>"D000009886", "term"=>"Ophthalmoplegia"}, {"id"=>"D000015835", "term"=>"Ocular Motility Disorders"}, {"id"=>"D000003389", "term"=>"Cranial Nerve Diseases"}, {"id"=>"D000024801", "term"=>"Tauopathies"}, {"id"=>"D000019636", "term"=>"Neurodegenerative Diseases"}, {"id"=>"D000005128", "term"=>"Eye Diseases"}], "browseLeaves"=>[{"id"=>"M13157", "name"=>"Paralysis", "asFound"=>"Palsy", "relevance"=>"HIGH"}, {"id"=>"M16275", "name"=>"Supranuclear Palsy, Progressive", "asFound"=>"Progressive Supranuclear Palsy", "relevance"=>"HIGH"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"M25603", "name"=>"Ganglion Cysts", "relevance"=>"LOW"}, {"id"=>"M16358", "name"=>"Synovial Cyst", "relevance"=>"LOW"}, {"id"=>"M4774", "name"=>"Basal Ganglia Diseases", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M12029", "name"=>"Movement Disorders", "relevance"=>"LOW"}, {"id"=>"M12817", "name"=>"Ophthalmoplegia", "relevance"=>"LOW"}, {"id"=>"M18386", "name"=>"Ocular Motility Disorders", "relevance"=>"LOW"}, {"id"=>"M6605", "name"=>"Cranial Nerve Diseases", "relevance"=>"LOW"}, {"id"=>"M23002", "name"=>"Tauopathies", "relevance"=>"LOW"}, {"id"=>"M21558", "name"=>"Neurodegenerative Diseases", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}, {"id"=>"T4741", "name"=>"Progressive Supranuclear Palsy", "asFound"=>"Progressive Supranuclear Palsy", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>75}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-12-12", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-12", "completionDateStruct"=>{"date"=>"2025-07-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2023-12-11", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Change from the baseline in the total score of PSP-rating scale", "timeFrame"=>"18 months", "description"=>"Change from the baseline in the total score of PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 72 weeks (18 months) of investigational product administration. The possible total scores range from 0 to 100 with a higher score indicating severely impaired cognitive function."}, {"measure"=>"Change from the baseline in the score of each domain of the PSP-rating scale", "timeFrame"=>"18 months", "description"=>"Change from the baseline in the score of each domain of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 72 weeks (18 months) and 24 weeks (6 months) of investigational product administration. Each domain is rated from different range (0 to 8, 16, 20 or 24) with a higher total score indicating severely impaired cognitive function."}, {"measure"=>"Change from the baseline in the score of each item of the PSP-rating scale", "timeFrame"=>"18 months", "description"=>"Change from the baseline in the score of each item of the PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 72 weeks (18 months) of investigational product administration. Each item is rated from different range (0 to 2 or 4) with a higher total score indicating severely impaired cognitive function."}, {"measure"=>"Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK)", "timeFrame"=>"18 months", "description"=>"Change from the baseline in the Montreal Cognitive Assessment - Korea (MoCAK) after 72 weeks (18 months) of investigational product administration. The possible total scores range from 0 to 30 with a higher score indicating greater cognitive function."}, {"measure"=>"Change from the baseline in the Korean Frontal Assessment Battery (K-FAB)", "timeFrame"=>"18 months", "description"=>"Change from the baseline in the Korean Frontal Assessment Battery (K-FAB) after 72 weeks (18 months) of investigational product administration. The possible total scores range from 0 to 18 with a higher score indicating greater cognitive function."}, {"measure"=>"Change from the baseline in the England & Schwab Activity of Daily Living (ES ADL) scale", "timeFrame"=>"18 months", "description"=>"Change from the baseline in the England \\& Schwab Activity of Daily Living (ES ADL) scale after 72 weeks (18 months) of investigational product administration. The possible total scores range from 0 (complete dependence) to 100% (complete independence) based on the level of independence."}], "primaryOutcomes"=>[{"measure"=>"Adverse Event", "timeFrame"=>"12 months", "description"=>"Adverse Event"}, {"measure"=>"Change in Hematological tests WBC(10^3/µl)", "timeFrame"=>"12 months", "description"=>"WBC(10\\^3/µl)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematological tests RBC(10^6/µl)", "timeFrame"=>"12 months", "description"=>"RBC(10\\^6/µl)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematological tests Hemoglobin(g/dL)", "timeFrame"=>"12 months", "description"=>"Hemoglobin(g/dL)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematological tests Hematocrit(%)", "timeFrame"=>"12 months", "description"=>"Hematocrit(%)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematological tests Platelets count(10^3/µl)", "timeFrame"=>"12 months", "description"=>"Platelets count(10\\^3/µl)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematological tests WBC differential count (Neutrophils(%))", "timeFrame"=>"12 months", "description"=>"WBC differential count (Neutrophils(%)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematological tests WBC differential count( Lymphocytes(%))", "timeFrame"=>"12 months", "description"=>"Lymphocytes(%)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematological tests WBC differential count( Monocytes(%))", "timeFrame"=>"12 months", "description"=>"Monocytes(%)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematological tests WBC differential count(Eosinophils(%))", "timeFrame"=>"12 months", "description"=>"Eosinophils(%)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematological tests WBC differential count(Basophils(%))", "timeFrame"=>"12 months", "description"=>"Basophils(%)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematochemical tests BUN(mg/dL)", "timeFrame"=>"12 months", "description"=>"BUN(mg/dL)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematochemical tests Creatinine(mg/dL)", "timeFrame"=>"12 months", "description"=>"Creatinine(mg/dL)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematochemical tests Uric acid(mg/dL)", "timeFrame"=>"12 months", "description"=>"Uric acid(mg/dL)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematochemical tests Total bilirubin(mg/dL)", "timeFrame"=>"12 months", "description"=>"Total bilirubin(mg/dL)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematochemical tests Albumin(g/dL)", "timeFrame"=>"12 months", "description"=>"Albumin(g/dL)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematochemical tests Total Protein(g/dL)", "timeFrame"=>"12 months", "description"=>"Total Protein(g/dL)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematochemical tests ALT(U/L)", "timeFrame"=>"12 months", "description"=>"ALT(U/L)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematochemical tests AST(U/L)", "timeFrame"=>"12 months", "description"=>"AST(U/L)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematochemical tests γ-GTP(U/L)", "timeFrame"=>"12 months", "description"=>"γ-GTP(U/L)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematochemical tests Alkaline phosphatase(U/L)", "timeFrame"=>"12 months", "description"=>"Alkaline phosphatase(U/L)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematochemical tests Glucose(mg/dL)", "timeFrame"=>"12 months", "description"=>"Glucose(mg/dL)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in Hematochemical tests Total Cholesterol(mg/dL)", "timeFrame"=>"12 months", "description"=>"Total Cholesterol(mg/dL)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in urine tests Protein-Albumin(mg/dL)", "timeFrame"=>"12 months", "description"=>"Protein-Albumin(mg/dL)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in urine tests Glucose(mg/dL)", "timeFrame"=>"12 months", "description"=>"Glucose(mg/dL)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in urine tests Ketones(mg/dL)", "timeFrame"=>"12 months", "description"=>"Ketones(mg/dL)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in urine tests WBC(HPF)", "timeFrame"=>"12 months", "description"=>"WBC(HPF)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Change in urine tests Blood-RBC(HPF)", "timeFrame"=>"12 months", "description"=>"Blood-RBC(HPF)\n\nFor the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group"}, {"measure"=>"Blood Pressure (mmHG)", "timeFrame"=>"12 months", "description"=>"Change in Blood Pressure (mmHG)"}, {"measure"=>"Pulse rate(beats per min)", "timeFrame"=>"12 months", "description"=>"Change in Pulse rate(beats per min)"}, {"measure"=>"Respiratory rate(breaths per min)", "timeFrame"=>"12 months", "description"=>"Change in Respiratory rate(breaths per min)"}, {"measure"=>"temperature(℃)", "timeFrame"=>"12 months", "description"=>"Change in temperature(℃)"}, {"measure"=>"EKG", "timeFrame"=>"12 months", "description"=>"EKG result(normal or abnormal)"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Progressive Supranuclear Palsy GV1001"], "conditions"=>["Progressive Supranuclear Palsy"]}, "descriptionModule"=>{"briefSummary"=>"The study will be conducted by the Sponsor to evaluate Twelve-months Long-Term Safety and Efficacy of GV1001 (1.12 mg) administered subcutaneously as a treatment for Progressive Supranuclear Palsy(PSP). In 75 patients diagnosed with PSP Richardson(PSP-RS) or PSP-Parkinsonism (PSP-P) who Completed Study GV1001-PSP-CL2-011.", "detailedDescription"=>"In GV1001-PSP-CL2-011 study, subjects who were in the trial group (Study Group 1(GV1001 0.56 mg/day), Study Group 2(GV1001 1.12 mg/day) is alternately administered High-dose test drug(GV1001 1.12 mg/day) and placebo once a week from Ex-Visit 1(Visit 16, Week 26) to Ex-Visit 5(Visit 20, Week 30) and High-dose test drugs(GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks.\n\nIn the GV1001-PSP-CL2-011 study, subjects who were in the placebo group are administered placebo at Ex-Visit 1 (Visit16, Week26), the first visit of the extension study, and Ex-Visit 2 (Visit17, Week27) to Ex-Visit 5 (Visit 20, Week 30), High-dose test drugs(GV1001 1.12 mg/day) are administered once a week and High-dose test drugs (GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"41 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* A person who has been registered in the GV1001-PSP-CL2-011 clinical trial and has completed administration by Week 24\n* A patient who accompanied all visits with the subject for the scheduled visit of this clinical trial, has a guardian who can supervise the subject's compliance with the examination and examination procedures conducted at the time of the visit, and provides information on the subject's indications, and whose guardian has agreed in writing to participate in the clinical trial (except where it is unnecessary to accompany the guardian at the discretion of the investigator)\n* Patient and/or representative of the patient who has voluntarily agreed in writing to participate in this clinical trial\n\nExclusion Criteria:\n\n* Patients deemed unsuitable by the investigator to participate in this extension study\n* Pregnant or male subjects who do not consent to contraception by medically approved methods (surgical infertility, intrauterine contraceptive devices, fallopian tube ligature, double blocking (combined use of male condoms, female condoms, cervical caps, contraceptive diaphragm and sponges) and 90 days after clinical trial participation However, women who have undergone menopause or surgical infertility procedures (such as vasectomy and difficult conception on both sides) before participating in clinical trials can participate without consent to contraception.\n* Pregnant women or breastfeeding women"}, "identificationModule"=>{"nctId"=>"NCT06235775", "briefTitle"=>"Administration of GV1001 for the Treatment of Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"GemVax & Kael"}, "officialTitle"=>"Twelve-months Extension Study to Explore the Long-Term Safety and Efficacy of Subcutaneous Administration of GV1001 1.12 mg/Day in Patients With Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011", "orgStudyIdInfo"=>{"id"=>"GV1001-PSP-CL2-011-E"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"GV1001 1.12 mg", "description"=>"In GV1001-PSP-CL2-011 study, subjects who were in the trial group (Study Group 1(GV1001 0.56 mg/day), Study Group 2(GV1001 1.12 mg/day) is alternately administered High-dose test drug(GV1001 1.12 mg/day) and placebo once a week from Ex-Visit 1(Visit 16, Week 26) to Ex-Visit 5(Visit 20, Week 30) and High-dose test drugs(GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks.\n\nIn the GV1001-PSP-CL2-011 study, subjects who were in the placebo group are administered placebo at Ex-Visit 1 (Visit16, Week26), the first visit of the extension study, and Ex-Visit 2 (Visit17, Week27) to Ex-Visit 5 (Visit 20, Week 30), High-dose test drugs(GV1001 1.12 mg/day) are administered once a week and High-dose test drugs (GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks.", "interventionNames"=>["Drug: GV1001 Placebo", "Drug: GV1001 1.12mg"]}], "interventions"=>[{"name"=>"GV1001 Placebo", "type"=>"DRUG", "otherNames"=>["Normal saline"], "description"=>"0.9% normal saline", "armGroupLabels"=>["GV1001 1.12 mg"]}, {"name"=>"GV1001 1.12mg", "type"=>"DRUG", "otherNames"=>["Tertomotide 1.68mg"], "description"=>"Lyophilized peptide from hTERT", "armGroupLabels"=>["GV1001 1.12 mg"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Seongnam-si", "status"=>"NOT_YET_RECRUITING", "country"=>"Korea, Republic of", "contacts"=>[{"name"=>"Jong-Min Kim", "role"=>"CONTACT"}, {"name"=>"Jong-Min Kim", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Seoul National University Bundang Hospital", "geoPoint"=>{"lat"=>37.43861, "lon"=>127.13778}}, {"city"=>"Seoul", "status"=>"NOT_YET_RECRUITING", "country"=>"Korea, Republic of", "contacts"=>[{"name"=>"Tae-Beom Ahn", "role"=>"CONTACT"}, {"name"=>"Tae-Beom Ahn", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Kyung Hee University Hospital", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}, {"city"=>"Seoul", "status"=>"NOT_YET_RECRUITING", "country"=>"Korea, Republic of", "contacts"=>[{"name"=>"Jin Whan Cho", "role"=>"CONTACT"}, {"name"=>"Jin Whan Cho", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Samsung Medical Center", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}, {"city"=>"Seoul", "status"=>"RECRUITING", "country"=>"Korea, Republic of", "contacts"=>[{"name"=>"Jee-Young Lee", "role"=>"CONTACT"}, {"name"=>"Jee-Young Lee", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Seoul Metropolitan Government Seoul National University Boramae Medical Center", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}, {"city"=>"Seoul", "status"=>"NOT_YET_RECRUITING", "country"=>"Korea, Republic of", "contacts"=>[{"name"=>"Han-Joon Kim", "role"=>"CONTACT"}, {"name"=>"Han-Joon Kim", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Seoul National University Hospital", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}], "centralContacts"=>[{"name"=>"Mino Moon", "role"=>"CONTACT", "email"=>"clinical@gemvax.com", "phone"=>"+82 70 4738 9726"}], "overallOfficials"=>[{"name"=>"Sang Jae Kim", "role"=>"STUDY_CHAIR", "affiliation"=>"GemVax & Kael"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"GemVax & Kael", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
