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Completed

NCT Number: NCT01196507

Early Primary Prophylaxis of Esophageal Varices

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.

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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, 110 070, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • Any contra-indication to beta-blockers
  • Any EVL or sclerotherapy within last 3 months
  • Child Turcotte Pugh (CTP) score > 12, refractory ascites, hepatorenal syndrome
  • Any past history of surgery for portal hypertension
  • Significant cardio or pulmonary co-morbidity
  • Any malignancy that affects survival.
  • Active alcohol abuse or last intake ≤ 4 weeks to avoid possibility of ongoing alcohol hepatitis.
  • Past history of surgery for portal hypertension
  • Uncontrolled diabetes
  • Peripheral vascular disease
  • 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 or with a maximum of 12.5 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 4 BD.

Primary outcomes

  1. 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

Secondary outcomes

  1. Survival

    Time frame: 2 Years

  2. adverse effects of drugs

    Time frame: 2 Years

  3. reduction in HVPG

    Time frame: 1 Year

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 Early Primary Prophylaxis of Esophageal Varices in Cirrhosis.

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 8, 2010
Registry last updated
Jun 15, 2016

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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