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

All India Institute Of Medical Science (AIIMS)

Status and phase: Unknown; Phase 2

Conditions: Acute on Chronic Hepatic Failure; Liver Failure; Hepatitis E Infection

Treatments: Drug: Ribavirin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01698723

HEV-RIBA

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Ribavirin

Active Comparator group

Description:

1000 mg (5 capsules)

Treatment:

Drug: Ribavirin

Placebo

Placebo Comparator group

Description:

5 capsules of placebo

Treatment:

Drug: Placebo