A Trial of Ribavirin in Patients With ACLF Due to Hepatitis E Virus

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-06-30

Brief Summary

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The term Acute on chronic liver failure (ACLF) describes a clinical entity characterized by an acute and rapid deterioration of liver function in a patient with previously well-compensated liver disease owing to the effects of a precipitating event. In this condition two insults act simultaneously, one being the preexisting liver injury (chronic liver disease) and the other acute injury which is responsible for the acute decompensation. HEV being a major factor responsible for this clinical entity and has a very high mortality rate. Ribavirin being a safe drug and has been shown to inhibit the replication of HEV, can be an important drug in the treatment of these patients. Therefore the present study is designed to study the impact of Ribavirin in reducing the mortality due to HEV related ACLF.

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Detailed Description

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Conditions

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Acute on Chronic Hepatic Failure Liver Failure Hepatitis E Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ribavirin

1000 mg (5 capsules)

Group Type ACTIVE_COMPARATOR

Ribavirin

Intervention Type DRUG

Placebo

5 capsules of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Ribavirin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All ACLF due to HEV
* Consent to participate in trial and collection of blood.

Exclusion Criteria

* Pregnant and nursing mothers.
* Severe anemia
* Other etiologies of ACLF (eg. Alcohol, drugs, reactivation of hepatitis B and hepatitis C, variceal bleeding, surgical intervention and sepsis)
* Hepatocellular carcinoma (HCC)
* Hepatorenal syndrome (HRS) at admission
* Presence of life threatening cardiovascular, respiratory and neurological disease
* Acquired Immunodeficiency Syndrome
* Patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)
* Refusal to provide consent to participate in the study

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No