Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

NCT ID: NCT01212250

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-01

Study Completion Date

2026-12-31

Brief Summary

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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 Description

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Conditions

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Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Carvedilol

Tablet 6.25 mg BD

Group Type EXPERIMENTAL

carvedilol

Intervention Type 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

Placebo tablets 2 BD

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Dr Ankur Jindal, DM

Role: CONTACT

011-46300000

Dr Ankit Bhardwaj, PhD (Epidemiology)

Role: CONTACT

01146300000

Facility Contacts

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Ankur Jindal, DM

Role: primary

9582670984

Other Identifiers

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ILBS PHT-003

Identifier Type: -

Identifier Source: org_study_id

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