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

Study Overview
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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.

Official Title
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A Double Blind Placebo Controlled Randomized Trial of Ribavirin in Patients With Acute on Chronic Liver Failure Due to Hepatitis E Virus

Conditions
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Acute on Chronic Hepatic Failure, Liver Failure, Hepatitis E Infection

Intervention / Treatment
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* Drug: Ribavirin
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ribavirin<br>1000 mg (5 capsules) | Drug: Ribavirin<br> <br> |
| Placebo Comparator: Placebo<br>5 capsules of placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in survival |  | 4 weeks and 12 moths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Score | Change in Child Score will be evaluated at every 4 week interval | 4 weeks and 12 months | 
| Viremia | Change in viral load | 4 weeks, 3 months | 
| Variceal bleeding | Variceal bleeding will be assessed every 4 weeks | 4 weeks and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACLF, HEV, Ribavirin