Ribavirin for Severe Acute and Chronic Hepatitis E Virus Infection.

• Status: Terminated
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Treatments: Ribavirin

Criteria

Inclusion Criteria:

• Age equal or greater than 18 years.

• To comply with any of the following diagnoses:

• chronic Hepatitis E: HEV RNA detectable in patients with elevated transaminase levels for at least 6 months and / or HEV RNA detectable in two separated determinations by an interval of six months .

• severe acute Hepatitis E: alanine aminotransferase (ALT) levels greater than 10 times the normal limit, with HEV RNA positive, and signs of acute liver injury (International normalized ratio(INR> 1.5)); or with extrahepatic manifestations or liver failure in patients with previous liver disease.

• Signed informed consent

Exclusion Criteria:

• Terminal illness with a expected life expectancy of less than 6 months

• Patients with contraindications for treatment with Ribavirin:

• pregnancy or lactation.

• Severe hepatic impairment or decompensated cirrhosis.

• hemoglobinopathies (thalassemia, sickle cell anemia).

• history of severe pre-existing cardiac disease, including unstable heart disease.