Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
1 other identifier
interventional
132
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 7, 2010
CompletedFirst Posted
Study publicly available on registry
September 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
August 13, 2025
August 1, 2025
16.3 years
September 7, 2010
August 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
the proportions of patients who develop esophageal varices at 1 year in each group.
1 year
Secondary Outcomes (3)
Number of patient dying in a period of one year
1 year
Number of patients needing discontinuation of therapy due to adverse effects.
1 year
Reduction in Hepatic Venous Pressure Gradient in both groups
1 year
Study Arms (2)
Carvedilol
EXPERIMENTALTablet 6.25 mg BD
placebo
PLACEBO COMPARATORPlacebo tablets 2 BD
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients of cirrhosis aged 18 to 75 years who have no esophageal or gastric varices.
You may not qualify if:
- Any contra-indication to beta-blockers
- Any past EVL or sclerotherapy
- Any past history of surgery for portal hypertension
- Significant cardio or pulmonary co-morbidity
- Any malignancy
- Refusal to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2010
First Posted
September 30, 2010
Study Start
September 1, 2010
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
August 13, 2025
Record last verified: 2025-08