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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01698723
First received: September 27, 2012
Last updated: September 29, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Acute on Chronic Hepatic Failure
Liver Failure
Hepatitis E Infection
Drug: Ribavirin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Placebo Controlled Randomized Trial of Ribavirin in Patients With Acute on Chronic Liver Failure Due to Hepatitis E Virus

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Improvement in survival [ Time Frame: 4 weeks and 12 moths ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Child Score [ Time Frame: 4 weeks and 12 months ] [ Designated as safety issue: Yes ]
    Change in Child Score will be evaluated at every 4 week interval

  • Viremia [ Time Frame: 4 weeks, 3 months ] [ Designated as safety issue: No ]
    Change in viral load

  • Variceal bleeding [ Time Frame: 4 weeks and 12 months ] [ Designated as safety issue: No ]
    Variceal bleeding will be assessed every 4 weeks


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ribavirin
1000 mg (5 capsules)
Drug: Ribavirin
Placebo Comparator: Placebo
5 capsules of placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698723

Contacts
Contact: Subrat K Acharya, DM +91-11-26594934 subratacharya2004@yahoo.com
Contact: Shalimar ., DM +919968405815

Locations
India
AII India Institute of Medical Sciences Recruiting
Delhi, India, 110029
Contact: Subrat K Acharya, DM    +91-11-26594934    subratacharya2004@yahoo.com   
Contact: Shalimar ., DM    +91-9968405815    drshalimar@yahoo.com   
Principal Investigator: Subrat K Acharya, DM         
All India Institute of Medical Sciences Recruiting
Delhi, India, 110029
Contact: Subrat K Acharya, DM    +91-11-26594934    subratacharya2004@yahoo.com   
Contact: Shalimar ., DM    +91-9968405815    drshalimar@yahoo.com   
Principal Investigator: Subrat K Acharya, DM         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Subrat K Acharya, DM All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: Subrat Kumar Acharya, Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01698723     History of Changes
Other Study ID Numbers: HEV-RIBA
Study First Received: September 27, 2012
Last Updated: September 29, 2012
Health Authority: India: Ministry of Health

Keywords provided by All India Institute of Medical Sciences, New Delhi:
ACLF
HEV
Ribavirin

Additional relevant MeSH terms:
Hepatitis E
Hepatitis
Hepatitis A
Liver Failure
Liver Failure, Acute
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepatic Insufficiency
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014