Nctid:
NCT06236165
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007565", "term"=>"Jaundice"}], "ancestors"=>[{"id"=>"D000006932", "term"=>"Hyperbilirubinemia"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000012877", "term"=>"Skin Manifestations"}], "browseLeaves"=>[{"id"=>"M10595", "name"=>"Jaundice", "asFound"=>"Jaundice", "relevance"=>"HIGH"}, {"id"=>"M9983", "name"=>"Hyperbilirubinemia", "relevance"=>"LOW"}, {"id"=>"M15680", "name"=>"Skin Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000000111", "term"=>"Acetylcysteine"}, {"id"=>"D000010431", "term"=>"Pentoxifylline"}, {"id"=>"C000030905", "term"=>"N-monoacetylcystine"}], "ancestors"=>[{"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000005100", "term"=>"Expectorants"}, {"id"=>"D000019141", "term"=>"Respiratory System Agents"}, {"id"=>"D000016166", "term"=>"Free Radical Scavengers"}, {"id"=>"D000000975", "term"=>"Antioxidants"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000020011", "term"=>"Protective Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000000931", "term"=>"Antidotes"}, {"id"=>"D000010726", "term"=>"Phosphodiesterase Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000010975", "term"=>"Platelet Aggregation Inhibitors"}, {"id"=>"D000011837", "term"=>"Radiation-Protective Agents"}, {"id"=>"D000014665", "term"=>"Vasodilator Agents"}], "browseLeaves"=>[{"id"=>"M13342", "name"=>"Pentoxifylline", "asFound"=>"Blood test", "relevance"=>"HIGH"}, {"id"=>"M3475", "name"=>"Acetylcysteine", "asFound"=>"Until disease progression", "relevance"=>"HIGH"}, {"id"=>"M244107", "name"=>"N-monoacetylcystine", "asFound"=>"Begin", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M8243", "name"=>"Expectorants", "relevance"=>"LOW"}, {"id"=>"M21137", "name"=>"Respiratory System Agents", "relevance"=>"LOW"}, {"id"=>"M4292", "name"=>"Antioxidants", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}, {"id"=>"M4250", "name"=>"Antidotes", "relevance"=>"LOW"}, {"id"=>"M13629", "name"=>"Phosphodiesterase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M13865", "name"=>"Platelet Aggregation Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14684", "name"=>"Radiation-Protective Agents", "relevance"=>"LOW"}, {"id"=>"M17412", "name"=>"Vasodilator Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Vasodilator Agents", "abbrev"=>"VaDiAg"}, {"name"=>"Platelet Aggregation Inhibitors", "abbrev"=>"PlAggInh"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Respiratory System Agents", "abbrev"=>"Resp"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>66}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-14", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-02", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-02-14", "studyFirstSubmitDate"=>"2024-01-24", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-15", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-08", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change in total antioxidant capacity (TAC) level", "timeFrame"=>"The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.", "description"=>"Assessment of total antioxidant capacity (TAC) level by ELISA Kits according to manufacturer's instructions."}, {"measure"=>"Change in tumor necrosis factor alpha (TNF-α)", "timeFrame"=>"The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.", "description"=>"Assessment of tumor necrosis factor alpha (TNF-α) level by ELISA Kits according to manufacturer's instructions"}], "secondaryOutcomes"=>[{"measure"=>"Adverse events and toxicity", "timeFrame"=>"3 months.", "description"=>"Adverse events and toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5."}, {"measure"=>"Follow up of liver function", "timeFrame"=>"The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.", "description"=>"measurement of alanine transaminase (ALT) and aspartate transaminase (AST) both in U/L from blood samples will be assessed for all participants."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Jaundice, N-acetylcysteine, Pentoxifylline"], "conditions"=>["Hepatic and Post Hepatic Jaundice"]}, "descriptionModule"=>{"briefSummary"=>"Investigating the efficacy, safety, and molecular mechanism of both N-acetylcysteine and Pentoxifylline supplementation in improving elevated direct bilirubin level and liver function tests in patients with hepatic and post-hepatic jaundice."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients age 18-70 years old.\n* Patients diagnosed with jaundice and increased level direct bilirubin ≥ 3 mg/dL.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Nursing mothers.\n* Patients with increased indirect bilirubin level.\n* Patients who have Gilbert syndrome or Crigler Najjar syndrome.\n* Patients with Child Paugh C score (10-15 point).\n* History of intolerance and hypersensitivity to Pentoxifylline or to xanthine derivatives such as caffeine, theophylline.\n* Recent hemorrhage.\n* Patients who have risk factors potentially complicated by hemorrhage.\n* Taking anticoagulants or antiplatelet therapy.\n* History of known hypersensitivity to N-acetylcysteine."}, "identificationModule"=>{"nctId"=>"NCT06236165", "briefTitle"=>"Clinical Study Evaluating Efficacy, Safety and Molecular Mechanism of Both N-acetylcysteine and Pentoxifylline Supplementation in Patients With Hepatic and Post Hepatic Jaundice", "organization"=>{"class"=>"OTHER", "fullName"=>"Tanta University"}, "officialTitle"=>"Clinical Study Evaluating Efficacy, Safety and Molecular Mechanism of Both N-acetylcysteine and Pentoxifylline Supplementation in Patients With Hepatic and Post Hepatic Jaundice", "orgStudyIdInfo"=>{"id"=>"00543/2024"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"NO_INTERVENTION", "label"=>"Control arm", "description"=>"22 patients who will receive supportive treatment for jaundice only, for 3 months."}, {"type"=>"EXPERIMENTAL", "label"=>"NAC arm", "description"=>"22 patients who will receive oral N-acetylcysteine 600 mg twice daily in addition to supportive treatment, for 3 months.", "interventionNames"=>["Drug: N-acetylcysteine"]}, {"type"=>"EXPERIMENTAL", "label"=>"PTX arm", "description"=>"22 patients who will receive oral Pentoxifylline 400 mg twice daily in addition to supportive treatment, for 3 months.", "interventionNames"=>["Drug: Pentoxifylline"]}], "interventions"=>[{"name"=>"N-acetylcysteine", "type"=>"DRUG", "description"=>"Patients will receive oral N-acetylcysteine 600 mg twice daily in addition to supportive treatment, for 3 months.", "armGroupLabels"=>["NAC arm"]}, {"name"=>"Pentoxifylline", "type"=>"DRUG", "description"=>"Patients will receive oral Pentoxifylline 400 mg twice daily in addition to supportive treatment, for 3 months.", "armGroupLabels"=>["PTX arm"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"31111", "city"=>"Tanta", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"Samah Hussein", "role"=>"CONTACT", "email"=>"samah_hussein@pharm.tanta.edu.eg", "phone"=>"0020403336007"}], "facility"=>"Faculty of Pharmacy, Tanta University", "geoPoint"=>{"lat"=>30.78847, "lon"=>31.00192}}], "centralContacts"=>[{"name"=>"Samah Hussein, master degree", "role"=>"CONTACT", "email"=>"samahhusseinm@gmail.com", "phone"=>"00201010604086"}], "overallOfficials"=>[{"name"=>"Samah Hussein", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"faculty of pharmacy Tanta University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Tanta University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Master degree in Clinical Pharmacy", "investigatorFullName"=>"Samah Hussein Mohamed", "investigatorAffiliation"=>"Tanta University"}}}}
