Clinical Trial: Early Primary Prophylaxis of Esophageal Varices
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Early Primary Prophylaxis of Esophageal Varices in Cirrhosis.
Brief Summary: Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously 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. The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) at 1 year in each group. The secondary endpoint are survival,reduction in HVPG,change in CTP and MELD score& adverse events.
Detailed Summary:
Sponsor: Institute of Liver and Biliary Sciences, India
Current Primary Outcome: The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) during the period of 2 year in each group. [ Time Frame: 2 Years ]
Original Primary Outcome: The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) at 1 year in each group. [ Time Frame: 1 year ]
Current Secondary Outcome:
- Survival [ Time Frame: 2 Years ]
- adverse effects of drugs [ Time Frame: 2 Years ]
- reduction in HVPG [ Time Frame: 1 Year ]
Original Secondary Outcome:
- development of complications of cirrhosis (ascites, hepatic encephalopathy, SBP), [ Time Frame: 1 year ]
- adverse effects of drugs [ Time Frame: 1 year ]
- Mortality [ Time Frame: 1 year ]
Information By: Institute of Liver and Biliary Sciences, India
Dates:
Date Received: September 4, 2010
Date Started: November 2010
Date Completion:
Last Updated: June 14, 2016
Last Verified: December 2013
