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NCT Number: NCT01212250

Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

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.

Recruiting

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, India

Location status: Recruiting

Location contact

Ankur Jindal, DM

CONTACT

[email protected]

9582670984

Ankur Jindal, MBBS, MD, DM

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carvedilol

Drug

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.

Placebo

Drug

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.

Primary outcomes

  1. the proportions of patients who develop esophageal varices at 1 year in each group.

    Time frame: 1 year

Secondary outcomes

  1. Number of patient dying in a period of one year

    Time frame: 1 year

  2. Number of patients needing discontinuation of therapy due to adverse effects.

    Time frame: 1 year

  3. Reduction in Hepatic Venous Pressure Gradient in both groups

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Ankit Bhardwaj, PhD (Epidemiology)

CONTACT

[email protected]

01146300000

Dr Ankur Jindal, DM

CONTACT

[email protected]

011-46300000

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

Important dates

Study start
2010
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2010
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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