Early Primary Prophylaxis of Esophageal Varices

Cirrhosis Clinical Trial

Official title:

A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Early Primary Prophylaxis of Esophageal Varices in Cirrhosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196507
• Other study ID #: ILBS PHT-02
• Status: Completed
• Phase: N/A
• First received: September 4, 2010
• Last updated: June 14, 2016
• Start date: November 2010
• Est. completion date: April 2014

Study information

• Verified date: December 2013
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cirrhosis

Intervention

Drug:
• 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 or with a maximum of 12.5 BD.
• 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 4 BD.

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences (ILBS)	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 Years	No
Secondary	Survival		2 Years	No
Secondary	adverse effects of drugs		2 Years	Yes
Secondary	reduction in HVPG		1 Year	No