NCT01698723

A Trial of Ribavirin in Patients With ACLF Due to Hepatitis E Virus

A Double Blind Placebo Controlled Randomized Trial of Ribavirin in Patients With Acute on Chronic Liver Failure Due to Hepatitis E Virus

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: All India Institute of Medical Sciences · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The term Acute on chronic liver failure (ACLF) describes a clinical entity characterized by an acute and rapid deterioration of liver function in a patient with previously well-compensated liver disease owing to the effects of a precipitating event. In this condition two insults act simultaneously, one being the preexisting liver injury (chronic liver disease) and the other acute injury which is responsible for the acute decompensation. HEV being a major factor responsible for this clinical entity and has a very high mortality rate. Ribavirin being a safe drug and has been shown to inhibit the replication of HEV, can be an important drug in the treatment of these patients. Therefore the present study is designed to study the impact of Ribavirin in reducing the mortality due to HEV related ACLF.

Conditions

• Acute on Chronic Hepatic Failure
• Liver Failure
• Hepatitis E Infection

Interventions

Type	Name	Description
DRUG	Ribavirin
DRUG	Placebo

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2012-10-03
• Last updated: 2016-04-26

Locations

2 sites across 1 country: India