Ribavirin for Severe Acute and Chronic Hepatitis E Virus Infection.

Phase 4

Terminated

• Conditions: Hepatitis E
• Interventions: Drug: Ribavirin

• Registration Number: NCT02558114
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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 Description

Not available

Study Timeline

• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Study Start: 2015-12
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Ribavirin	Patients will receive ribavirin during 12 weeks
Group B	Ribavirin	Patients will receive: * ribavirin during 12 weeks if RNA (Ribonucleic acid) Hepatitis E virus (HEV) is undetectable at week 4 after treatment start (adjust to renal function) * - ribavirin during 24 weeks if RNA (Ribonucleic acid) Hepatitis E virus (HEV) is detectable at week 4 after treatment start (adjust to renal function)

Primary Outcome Measures

Name	Time	Method
Sustained virological response measured by HEV RNA	48 weeks	HEV RNA undetectable at 48 weeks after end of treatment

Trial Locations

Locations (1)

Hospital Universitari vall d'Hebron; 🇪🇸 Barcelona, Spain