Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-29 @ 7:13 PM
Study NCT ID:
NCT06944704
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2025-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Efficacy, Safety and Molecular Mechanism of Pentoxifylline Supplementation in Patients With Hepatic and Obstructive Jaundice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007565', 'term': 'Jaundice'}], 'ancestors': [{'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010431', 'term': 'Pentoxifylline'}], 'ancestors': [{'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-27', 'studyFirstSubmitDate': '2025-04-18', 'studyFirstSubmitQcDate': '2025-04-18', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}}, '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 up to 12 weeks.', '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 up to 12 weeks.', 'description': "Assessment of tumor necrosis factor alpha (TNF-α) level by ELISA Kits according to manufacturer's instructions."}], 'secondaryOutcomes': [{'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 up to12 weeks.', 'description': 'measurement of alanine transaminase (ALT) and aspartate transaminase (AST) both in U/L from blood samples will be assessed for all participants.'}, {'measure': 'Adverse events and toxicity', 'timeFrame': 'up to 12 weeks', 'description': 'Adverse events and toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Jaundice', 'Pentoxifylline', 'TAC', 'TNF-α', 'Bilirubin'], 'conditions': ['Hepatobiliary Disorders']}, 'descriptionModule': {'briefSummary': 'Investigating the efficacy, safety, and molecular mechanism of 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\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.'}, 'identificationModule': {'nctId': 'NCT06944704', 'briefTitle': 'Evaluation of Efficacy, Safety and Molecular Mechanism of Pentoxifylline Supplementation in Patients With Hepatic and Obstructive Jaundice', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Clinical Study Evaluating Efficacy, Safety and Molecular Mechanism of Pentoxifylline Supplementation in Patients With Hepatic and Post Hepatic Jaundice', 'orgStudyIdInfo': {'id': 'TP/RE1/24Ph-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': '20 patients who will receive supportive treatment for jaundice only, for 3 months.'}, {'type': 'EXPERIMENTAL', 'label': 'PTX arm', 'description': '20 patients who will receive oral Pentoxifylline 400 mg twice daily in addition to supportive treatment, for 3 months.', 'interventionNames': ['Drug: Pentoxifylline']}], 'interventions': [{'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', 'country': 'Egypt', 'facility': 'Faculty of Pharmacy, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, M.Sc. in Clinical Pharmacy', 'investigatorFullName': 'Samah Hussein Mohamed', 'investigatorAffiliation': 'Tanta University'}}}}