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

Phase 2

• Conditions: Hepatitis E Infection; Liver Failure; Acute on Chronic Hepatic Failure
• Interventions: Drug: Placebo; Drug: Ribavirin

• Registration Number: NCT01698723
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-09-29
• Study First Posted: 2012-10-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-24
• Last Update Posted: 2016-04-26
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	5 capsules of placebo
Ribavirin	Ribavirin	1000 mg (5 capsules)

Primary Outcome Measures

Name	Time	Method
Improvement in survival	4 weeks and 12 moths

Secondary Outcome Measures

Name	Time	Method
Child Score	4 weeks and 12 months	Change in Child Score will be evaluated at every 4 week interval
Viremia	4 weeks, 3 months	Change in viral load
Variceal bleeding	4 weeks and 12 months	Variceal bleeding will be assessed every 4 weeks

Trial Locations

Locations (2)

AII India Institute of Medical Sciences; 🇮🇳 Delhi, India

All India Institute of Medical Sciences; 🇮🇳 Delhi, India