Ribavirin for Severe Acute and Chronic Hepatitis E Virus Infection.

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02558114

Enrollment

Registered

2015-09-23

Start date

2015-12-31

Completion date

2018-11-30

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis E

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.

Interventions

DRUGRibavirin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Sustained virological response measured by HEV RNA	48 weeks	HEV RNA undetectable at 48 weeks after end of treatment

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026