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

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Treatments: Ribavirin

Criteria

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