A Study to Prevent Complications of High Blood Pressure Caused by Hepatitis in Patients With Cirrhosis

Liver Cirrhosis Clinical Trial

Official title: Randomized, Double-Blind Study of Timolol (A Nonselective Beta-Adrenergic Blocker) vs Placebo to Prevent Complications of Hepatic Portal Hypertension in Patients With Cirrhosis

Status Completed

Clinical Trial Summary

OBJECTIVES:

I. Evaluate the efficacy of a certain drug in preventing intestinal complications in patients with cirrhosis and high blood pressure in the hepatic portal vein.

II. Evaluate vein pressure measurements to predict the development of internal bleeding.

Clinical Trial Description

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution, cirrhosis etiology, and hepatic venous pressure gradient.

The dose of oral timolol is titrated over 28 days. Patients are then randomly assigned to daily timolol at the titrated dose or a placebo if successful titration is achieved by day 28, and the final titration dose is maintained for at least 10 days. Timolol is discontinued prior to randomization.

Criteria for removal from study include esophageal or gastric varices, significant bleeding or hemorrhage, timolol-induced hepatic encephalopathy, and liver transplantation.

Patients are followed every 3 months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis

• NCT number: NCT00004641
• Study type: Interventional
• Source: Office of Rare Diseases (ORD)
• Status: Completed
• Phase: Phase 2
• Start date: May 1993