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

NCT01698723 | Unknown Phase 2 DMC

• 1 other identifier: HEV-RIBA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

ACLF; HEV; Ribavirin

Outcome Measures

Primary Outcomes (1)

• Improvement in survival

  4 weeks and 12 moths

Secondary Outcomes (3)

• Child Score

  4 weeks and 12 months

• Viremia

  4 weeks, 3 months

• Variceal bleeding

  4 weeks and 12 months

Study Arms (2)

Ribavirin

ACTIVE COMPARATOR

1000 mg (5 capsules)

Drug: Ribavirin

Placebo

PLACEBO COMPARATOR

5 capsules of placebo

Drug: Placebo

Interventions

Ribavirin DRUG

Ribavirin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All ACLF due to HEV
• Consent to participate in trial and collection of blood.

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (2)

AII India Institute of Medical Sciences

Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

All India Institute of Medical Sciences

Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Liver Failure

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Subrat K Acharya, DM

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Subrat K Acharya, DM

CONTACT

+91-11-26594934; subratacharya2004@yahoo.com

Shalimar ., DM

CONTACT

+919968405815

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 3, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 26, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

IN (2)