A Trial of Ribavirin in Patients With ACLF Due to Hepatitis E Virus (HEVRibavirin)
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ClinicalTrials.gov Identifier: NCT01698723
Recruitment Status : Unknown
Verified April 2016 by Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi. Recruitment status was: Recruiting
First Posted : October 3, 2012
Last Update Posted : April 26, 2016
All India Institute of Medical Sciences, New Delhi
Information provided by (Responsible Party):
Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi
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.
Condition or disease
Acute on Chronic Hepatic FailureLiver FailureHepatitis E Infection
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Ages Eligible for Study:
12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
All ACLF due to HEV
Consent to participate in trial and collection of blood.
Pregnant and nursing mothers.
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