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

April 24, 2016 updated by: Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Delhi, India, 110029
        • Recruiting
        • AII India Institute of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Subrat K Acharya, DM
        • Contact:
      • Delhi, India, 110029
        • Recruiting
        • All India Institute of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Subrat K Acharya, DM
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in survival
Time Frame: 4 weeks and 12 moths
4 weeks and 12 moths

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Investigators

  • Principal Investigator: Subrat K Acharya, DM, All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

September 27, 2012

First Submitted That Met QC Criteria

September 29, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Estimate)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 24, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEV-RIBA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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