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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: All India Institute of Medical Sciences, New Delhi

Current Primary Outcome: Improvement in survival [ Time Frame: 4 weeks and 12 moths ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Child Score [ Time Frame: 4 weeks and 12 months ]
  Change in Child Score will be evaluated at every 4 week interval
• Viremia [ Time Frame: 4 weeks, 3 months ]
  Change in viral load
• Variceal bleeding [ Time Frame: 4 weeks and 12 months ]
  Variceal bleeding will be assessed every 4 weeks

Original Secondary Outcome: Same as current

Information By: All India Institute of Medical Sciences, New Delhi

Dates:
Date Received: September 27, 2012
Date Started: September 2012
Date Completion: June 2016
Last Updated: April 24, 2016
Last Verified: April 2016