Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-28 @ 2:51 AM
Study NCT ID:
NCT02238860
Status:
UNKNOWN
Last Update Posted:
2014-09-12
First Post:
2014-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-11', 'studyFirstSubmitDate': '2014-09-10', 'studyFirstSubmitQcDate': '2014-09-11', 'lastUpdatePostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Outcome', 'timeFrame': '48 weeks', 'description': 'Death'}], 'primaryOutcomes': [{'measure': 'Safety and efficacy', 'timeFrame': '48 weeks', 'description': 'EFFICACY ENDPOINTS: EFFICACY ENDPOINTS INCLUDED PLASMA HBV DNA, ALT, HBEAG, HBSAG LOSS AND SEROCONVERION AS WELL AS CTP AND MELD SCORE.'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '48 weeks', 'description': 'SAFETY ENDPOINTS: SAFETY ANALYSIS INCLUDED CUMALATIVE RATES ON TREATMENT ADVERSE EVENTS, SEREIOUS ADVERSE EFFECTS DISCONTINUATION DUE TO SIDE EFFECTS,DEATH,HCC,RENAL IMPAIRMENT , HEPATIC FLARE AND DEVELOPMENT OF DRUG RESISTANCE.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis B', 'cirrhosis', 'Entacavir', 'enofovir'], 'conditions': ['Cirrhosis Due to Hepatitis B']}, 'descriptionModule': {'briefSummary': 'Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents have been claimed equivalent in treatment, there are no head to head trials available in the literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed to compare safety/efficacy and virological response in patients with HBV Decompensated Cirrhosis.', 'detailedDescription': 'The effectiveness of entacavir and tenofovir has not been prospectively studied in HBV Decompensated cirrhosis? This prospective, randomised clinical trial will help us in better patient management more efficacy and cost effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age (18 years- 70 years)\n* Hbv surface antigen positive \\> 6 months\n* HbeAg (positive or negative both)\n* Hbv DNA 10\\^3\n* ALT ULN\n* No evidence of HCC\n* Platelets count \\> 30 thousands\n* CTP score \\> 7\n* Hepatic encephalopathy (grade 1 - 2 only)\n* No prior Drug resistance\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* HCC patients\n* Prior drug resistance\n* Current HE \\> 2\n* Solid organ transplantation\n* Inadequate hematological function\n* Co infection with hepatitis C and HIV\n* Autoimmune disorders\n* Pregnancy and Breast feeding\n* Other hepatic diseases\n* Patients on immunosuppressant or chemotherapy agents'}, 'identificationModule': {'nctId': 'NCT02238860', 'briefTitle': 'A Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Asian Institute Of Medical Sciences'}, 'officialTitle': 'A Randomised Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis', 'orgStudyIdInfo': {'id': 'AIMS-hep B-123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Entacavir', 'description': 'Entacavir 0.5 mg (OD) for 48 weeks', 'interventionNames': ['Drug: Entacavir', 'Drug: Tenofovir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tenofovir', 'description': 'Tenofovir 300 mg ,OD for 48 weeks', 'interventionNames': ['Drug: Entacavir', 'Drug: Tenofovir']}], 'interventions': [{'name': 'Entacavir', 'type': 'DRUG', 'otherNames': ['ETV'], 'description': 'Entacavir-0.5 mg ,OD,for', 'armGroupLabels': ['Entacavir', 'Tenofovir']}, {'name': 'Tenofovir', 'type': 'DRUG', 'otherNames': ['TDF or PMPA'], 'description': 'Tenofovir ,300 mg,OD,for 48 weeks', 'armGroupLabels': ['Entacavir', 'Tenofovir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71800', 'city': 'Hyderābād', 'state': 'Sindh', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Dr mohammad sadik Memon, FCPS gastro', 'role': 'CONTACT', 'email': 'Sadikmemon@gmail.com', 'phone': '022-232593'}, {'name': 'Dr sadik Memon, FCPS gastro', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dr Madiha Zaki, MSC gastro', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dr NANDLAL Serani, FCPS gastro', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dr Umar Soomro, MBBS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Asian Institute of medical Sciences', 'geoPoint': {'lat': 25.39689, 'lon': 68.37718}}], 'centralContacts': [{'name': 'Dr mohammad sadik Memon, Fcps gastro', 'role': 'CONTACT', 'email': 'Sadikmemon@gmail.com', 'phone': '022-232593'}, {'name': 'Madiha Zaki, MSC gastro', 'role': 'CONTACT', 'email': 'Madiyaah@gmail.com', 'phone': '022-232593'}], 'overallOfficials': [{'name': 'Mohammad sadik Memon, Fcps gastro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AIMS Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asian Institute Of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of gastroenterology', 'investigatorFullName': 'Mohammad sadik memon', 'investigatorAffiliation': 'Asian Institute Of Medical Sciences'}}}}