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Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

Primary Purpose

Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
carvedilol
Placebo
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Liver & Biliary Sciences (ILBS)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Carvedilol

placebo

Arm Description

Tablet 6.25 mg BD

Placebo tablets 2 BD

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patient dying in a period of one year
Number of patients needing discontinuation of therapy due to adverse effects.
Reduction in Hepatic Venous Pressure Gradient in both groups

Full Information

First Posted
September 7, 2010
Last Updated
November 3, 2019
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT01212250
Brief Title
Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
Official Title
A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2010 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carvedilol
Arm Type
Experimental
Arm Description
Tablet 6.25 mg BD
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets 2 BD
Intervention Type
Drug
Intervention Name(s)
carvedilol
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
the proportions of patients who develop esophageal varices at 1 year in each group.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of patient dying in a period of one year
Time Frame
1 year
Title
Number of patients needing discontinuation of therapy due to adverse effects.
Time Frame
1 year
Title
Reduction in Hepatic Venous Pressure Gradient in both groups
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ankur Jindal, DM
Phone
011-46300000
Email
ankur.jindal3@gmail.com
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences (ILBS)
City
New Delhi
State/Province
Delhi
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ankur Jindal, DM
Phone
9582670984
Email
ankur.jindal3@gmail.com
First Name & Middle Initial & Last Name & Degree
Ankur Jindal, MBBS, MD, DM

12. IPD Sharing Statement

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Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

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