Clinical Trial: Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
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.
Detailed Summary:
Sponsor: Institute of Liver and Biliary Sciences, India
Current Primary Outcome: the proportions of patients who develop esophageal varices at 1 year in each group. [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of patient dying in a period of one year [ Time Frame: 1 year ]
- Number of patients needing discontinuation of therapy due to adverse effects. [ Time Frame: 1 year ]
- Reduction in Hepatic Venous Pressure Gradient in both groups [ Time Frame: 1 year ]
Original Secondary Outcome:
- complications of cirrhosis (ascites, hepatic encephalopathy, SBP), [ Time Frame: 1 year ]
- Number of patient dying in a period of one year [ Time Frame: 1 year ]
- Number of patients needing discontinuation of therapy due to adverse effects. [ Time Frame: 1 year ]
Information By: Institute of Liver and Biliary Sciences, India
Dates:
Date Received: September 7, 2010
Date Started: September 2010
Date Completion: December 2017
Last Updated: February 28, 2017
Last Verified: September 2016
