Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

Overview

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.

Full Title of Study: “A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 1, 2020

Interventions

  • Drug: carvedilol
    • 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.
  • Drug: Placebo
    • 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.

Arms, Groups and Cohorts

  • Experimental: Carvedilol
    • Tablet 6.25 mg BD
  • Placebo Comparator: placebo
    • Placebo tablets 2 BD

Clinical Trial Outcome Measures

Primary Measures

  • the proportions of patients who develop esophageal varices at 1 year in each group.
    • Time Frame: 1 year

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Patients of cirrhosis aged 18 to 75 years who have no esophageal or gastric varices. Exclusion Criteria:

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institute of Liver and Biliary Sciences, India
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Ankur Jindal, DM, 011-46300000, ankur.jindal3@gmail.com

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