Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-28 @ 4:54 AM
Study NCT ID:
NCT01212250
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2010-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077261', 'term': 'Carvedilol'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2010-09-07', 'studyFirstSubmitQcDate': '2010-09-29', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the proportions of patients who develop esophageal varices at 1 year in each group.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Number of patient dying in a period of one year', 'timeFrame': '1 year'}, {'measure': 'Number of patients needing discontinuation of therapy due to adverse effects.', 'timeFrame': '1 year'}, {'measure': 'Reduction in Hepatic Venous Pressure Gradient in both groups', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cirrhosis']}, 'descriptionModule': {'briefSummary': 'Patients of cirrhosis aged 18 to 75 years who have no esophageal varices will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 12.5 mg BD. After randomization they will be followed up for one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of cirrhosis aged 18 to 75 years who have no esophageal or gastric varices.\n\nExclusion Criteria:\n\n* Any contra-indication to beta-blockers\n* Any past EVL or sclerotherapy\n* Any past history of surgery for portal hypertension\n* Significant cardio or pulmonary co-morbidity\n* Any malignancy\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT01212250', 'briefTitle': 'Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis', 'orgStudyIdInfo': {'id': 'ILBS PHT-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carvedilol', 'description': 'Tablet 6.25 mg BD', 'interventionNames': ['Drug: carvedilol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo tablets 2 BD', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'carvedilol', 'type': 'DRUG', 'description': 'Carvedilol will be administered orally at a start dose of 3.125 mg twice daily. After 1 week, this will increased if systolic blood pressure does not fall below 90 mm Hg. The patient will receive the maximum tolerated dose of carvedilol with a maximum of 6.25 BD.', 'armGroupLabels': ['Carvedilol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The placebo tablets will be identical to the carvedilol tablets. First the patients will receive placebo in the dose of 1 BD. Then depending on his tolerance it will be increased to a maximum of 2 BD.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Ankur Jindal, DM', 'role': 'CONTACT', 'email': 'ankur.jindal3@gmail.com', 'phone': '9582670984'}, {'name': 'Ankur Jindal, MBBS, MD, DM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Liver & Biliary Sciences (ILBS)', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'centralContacts': [{'name': 'Dr Ankur Jindal, DM', 'role': 'CONTACT', 'email': 'ankur.jindal3@gmail.com', 'phone': '011-46300000'}, {'name': 'Dr Ankit Bhardwaj, PhD (Epidemiology)', 'role': 'CONTACT', 'email': 'bhardwaj.ankit3@gmail.com', 'phone': '01146300000'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}