Clinical Trial: Ribavirin for Severe Acute and Chronic Hepatitis E Virus Infection.

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

Official Title: Randomized Study of Two Treatment Strategies With Ribavirin for Chronic Hepatitis E and Severe Acute Forms

Brief Summary:

The purpose of the study is to compare the efficacy, safety and recurrence rate of two therapeutic strategies with ribavirin in patients with chronic hepatitis E and severe acute hepatitis E: fixed duration of treatment for 12 weeks vs variable duration depending on the viremia within 4 weeks of the start of treatment (12 vs 24 weeks).

The purpose of the study is also improve the safety of treatment with Ribavirin by optimizing dose adjusted to renal function, plasma levels of drug and hemoglobin.


Detailed Summary:
Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Current Primary Outcome: Sustained virological response measured by HEV RNA [ Time Frame: 48 weeks ]

HEV RNA undetectable at 48 weeks after end of treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hospital Universitari Vall d'Hebron Research Institute

Dates:
Date Received: September 18, 2015
Date Started: December 2015
Date Completion: October 2018
Last Updated: February 24, 2016
Last Verified: February 2016