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

Primary Purpose

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

Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Ribavirin
Placebo
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute on Chronic Hepatic Failure focused on measuring ACLF, HEV, Ribavirin

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AII India Institute of Medical SciencesRecruiting
  • All India Institute of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ribavirin

Placebo

Arm Description

1000 mg (5 capsules)

5 capsules of placebo

Outcomes

Primary Outcome Measures

Improvement in survival

Secondary Outcome Measures

Child Score
Change in Child Score will be evaluated at every 4 week interval
Viremia
Change in viral load
Variceal bleeding
Variceal bleeding will be assessed every 4 weeks

Full Information

First Posted
September 27, 2012
Last Updated
April 24, 2016
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT01698723
Brief Title
A Trial of Ribavirin in Patients With ACLF Due to Hepatitis E Virus
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute on Chronic Hepatic Failure, Liver Failure, Hepatitis E Infection
Keywords
ACLF, HEV, Ribavirin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ribavirin
Arm Type
Active Comparator
Arm Description
1000 mg (5 capsules)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
5 capsules of placebo
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Improvement in survival
Time Frame
4 weeks and 12 moths
Secondary Outcome Measure Information:
Title
Child Score
Description
Change in Child Score will be evaluated at every 4 week interval
Time Frame
4 weeks and 12 months
Title
Viremia
Description
Change in viral load
Time Frame
4 weeks, 3 months
Title
Variceal bleeding
Description
Variceal bleeding will be assessed every 4 weeks
Time Frame
4 weeks and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Subrat K Acharya, DM
Phone
+91-11-26594934
Email
subratacharya2004@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shalimar ., DM
Phone
+919968405815
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subrat K Acharya, DM
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
AII India Institute of Medical Sciences
City
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Subrat K Acharya, DM
Phone
+91-11-26594934
Email
subratacharya2004@yahoo.com
First Name & Middle Initial & Last Name & Degree
Shalimar ., DM
Phone
+91-9968405815
Email
drshalimar@yahoo.com
First Name & Middle Initial & Last Name & Degree
Subrat K Acharya, DM
Facility Name
All India Institute of Medical Sciences
City
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Subrat K Acharya, DM
Phone
+91-11-26594934
Email
subratacharya2004@yahoo.com
First Name & Middle Initial & Last Name & Degree
Shalimar ., DM
Phone
+91-9968405815
Email
drshalimar@yahoo.com
First Name & Middle Initial & Last Name & Degree
Subrat K Acharya, DM

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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