Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-03 @ 12:02 AM
Study NCT ID:
NCT00369694
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2006-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Course Terlipressin for Control of Acute Variceal Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D004932', 'term': 'Esophageal and Gastric Varices'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D008551', 'term': 'Melena'}, {'id': 'D006396', 'term': 'Hematemesis'}, {'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077585', 'term': 'Terlipressin'}], 'ancestors': [{'id': 'D008236', 'term': 'Lypressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-24', 'studyFirstSubmitDate': '2006-08-24', 'studyFirstSubmitQcDate': '2006-08-24', 'lastUpdatePostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variceal Re-bleed', 'timeFrame': '120 hours (5 Days)'}], 'secondaryOutcomes': [{'measure': 'All cause 30 days mortality', 'timeFrame': '30 days'}, {'measure': '30 days rebleed', 'timeFrame': '30 days from index bleed'}, {'measure': 'Safety of Terlipressin', 'timeFrame': 'In Hospital safety'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Esophageal varices', 'Portal Hypertension', 'Melena', 'Hematemesis', 'Gastrointestinal Hemorrhage', 'Terlipressin', 'Efficacy', 'Safety'], 'conditions': ['Hemorrhage', 'Esophageal Varices', 'Portal Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether 24 hours of Terlipressin is as effective as 72 hours of Terlipressin in preventing re-bleed once esophageal variceal bleed has been controlled with endoscopic therapy (variceal band ligation or sclerotherapy) in low to moderate risk variceal bleed patients and hence can save cost and may decrease length of hospital stay especially in the I.C.U or high dependency units.', 'detailedDescription': 'The esophageal variceal bleeding is usually controlled with endoscopic treatment of variceal band ligation or sclerotherapy along with vasoactive drugs like Terlipressin or Octreotide. The risk of re-bleeding is highest during the initial 5 days from first presentation. Terlipressin is usually given for 3 days (72 hours). In this study we are trying to prove that among low to moderate risk patients, a short course of 1 day (24 hours) of Terlipressin is as effective as 3 days (72 hours) in preventing re-bleed once bleeding has been controlled with endoscopic therapy. This intervention will save 2 days cost incurred on the Terlipressin and may also help in decreasing the length of hospital stay in future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Acute esophageal variceal bleed\n* Liver cirrhosis\n* Child's score \\</= 11\n\nExclusion Criteria:\n\n* Patient on Mechanical ventilator and or ionotropic support\n* Active angina, Recent Myocardial infarction or dynamic EKG changes\n* Failure to control variceal bleed on initial endoscopy\n* Gastric variceal bleed\n* Spontaneous bacterial peritonitis at presentation\n* Hepatocellular carcinoma or other liver metastatic malignancy\n* Portal vein thrombosis"}, 'identificationModule': {'nctId': 'NCT00369694', 'briefTitle': 'Short Course Terlipressin for Control of Acute Variceal Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Randomized Double Blind Dummy Controlled Trial Of 24 Versus 72 Hours Of Terlipressin As An Adjuvant Therapy In Acute Variceal Bleed', 'orgStudyIdInfo': {'id': '446-Med/ERC-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '72 hours of Terlipressin', 'interventionNames': ['Drug: Terlipressin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': '24 hours of Terlipressin \\& then next 48 hours of Dummy of Terlipressin', 'interventionNames': ['Drug: Terlipressin & then Dummy']}], 'interventions': [{'name': 'Terlipressin', 'type': 'DRUG', 'otherNames': ['Novapressin'], 'description': '2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours', 'armGroupLabels': ['1']}, {'name': 'Terlipressin & then Dummy', 'type': 'DRUG', 'otherNames': ['Novapressin'], 'description': '2 mg Terlipressin stat then 1 mg q6 hours for 24 hours, then a Dummy of Terlipressin q6 hours for the next 48 hours.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74800', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'The Aga Khan University Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Saeed S Hamid, FRCP, FACG', 'role': 'STUDY_CHAIR', 'affiliation': 'The Aga Khan University Hospital'}, {'name': 'Zahid SM Azam, MBBS, FCPS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Aga Khan University Hospital'}, {'name': 'Wasim SM Jafri, FRCP, FACG', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Aga Khan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ferozsons Laboratories Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Ethical Review Committee (ERC)', 'oldOrganization': 'The Aga Khan University'}}}}