Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

Cirrhosis Clinical Trial

Official title:

A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01212250
• Other study ID #: ILBS PHT-003
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2010
• Est. completion date: December 1, 2020

Study information

• Verified date: November 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Ankur Jindal, DM
• Phone: 011-46300000
• Email: ankur.jindal3[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Esophageal and Gastric Varices
• Fibrosis
• 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 with a maximum of 6.25 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 2 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 proportions of patients who develop esophageal varices at 1 year in each group.		1 year
Secondary	Number of patient dying in a period of one year		1 year
Secondary	Number of patients needing discontinuation of therapy due to adverse effects.		1 year
Secondary	Reduction in Hepatic Venous Pressure Gradient in both groups		1 year