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Early Primary Prophylaxis of Esophageal Varices

Primary Purpose

Cirrhosis

Status
Completed
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 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

Sites / Locations

  • Institute of Liver & Biliary Sciences (ILBS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Carvedilol

Placebo

Arm Description

Tablet Carvedilol 12.5 mg BD or maximum tolerated dose

Placebo tablets 2 to 4 BD

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Survival
adverse effects of drugs
reduction in HVPG

Full Information

First Posted
September 4, 2010
Last Updated
June 14, 2016
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT01196507
Brief Title
Early Primary Prophylaxis of Esophageal Varices
Official Title
A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Early Primary Prophylaxis of Esophageal Varices in Cirrhosis.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

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 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.

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
Participant
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carvedilol
Arm Type
Experimental
Arm Description
Tablet Carvedilol 12.5 mg BD or maximum tolerated dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets 2 to 4 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 or with a maximum of 12.5 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 4 BD.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Survival
Time Frame
2 Years
Title
adverse effects of drugs
Time Frame
2 Years
Title
reduction in HVPG
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiv Kumar Sarin, MBBS, MD, DM
Organizational Affiliation
Institute of Liver & Biliary Sciences (ILBS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences (ILBS)
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 070
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
27298379
Citation
Bhardwaj A, Kedarisetty CK, Vashishtha C, Bhadoria AS, Jindal A, Kumar G, Choudhary A, Shasthry SM, Maiwall R, Kumar M, Bhatia V, Sarin SK. Carvedilol delays the progression of small oesophageal varices in patients with cirrhosis: a randomised placebo-controlled trial. Gut. 2017 Oct;66(10):1838-1843. doi: 10.1136/gutjnl-2016-311735. Epub 2016 Jun 13.
Results Reference
derived

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Early Primary Prophylaxis of Esophageal Varices

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