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

Liver Failure Clinical Trial

— HEVRibavirin  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01698723
• Other study ID #: HEV-RIBA
• Status: Recruiting
• Phase: Phase 2
• First received: September 27, 2012
• Last updated: April 24, 2016
• Start date: September 2012
• Est. completion date: June 2016

Study information

• Verified date: April 2016
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: Subrat K Acharya, DM
• Phone: +91-11-26594934
• Email: subratacharya2004[@]yahoo.com
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute on Chronic Hepatic Failure
• Hepatitis
• Hepatitis A
• Hepatitis E
• Hepatitis E Infection
• Liver Failure
• Liver Failure, Acute

Intervention

Drug:
• Ribavirin

• Placebo

Locations

Country	Name	City	State
India	AII India Institute of Medical Sciences	Delhi
India	All India Institute of Medical Sciences	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in survival		4 weeks and 12 moths	Yes
Secondary	Child Score	Change in Child Score will be evaluated at every 4 week interval	4 weeks and 12 months	Yes
Secondary	Viremia	Change in viral load	4 weeks, 3 months	No
Secondary	Variceal bleeding	Variceal bleeding will be assessed every 4 weeks	4 weeks and 12 months	No