Ribavirin for Severe Acute and Chronic Hepatitis E Virus Infection.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis E

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Patients will receive ribavirin during 12 weeks

Group Type OTHER

Ribavirin

Intervention Type DRUG

Group B

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)

Group Type OTHER

Ribavirin

Intervention Type DRUG

Interventions

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Ribavirin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No