Acute on Chronic Hepatic Failure, Hepatitis E Infection, Liver Failure
Conditions
Keywords
ACLF, HEV, Ribavirin
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.
Interventions
DRUGRibavirin
DRUGPlacebo
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in survival | 4 weeks and 12 moths |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Score | 4 weeks and 12 months | Change in Child Score will be evaluated at every 4 week interval |
| Viremia | 4 weeks, 3 months | Change in viral load |
| Variceal bleeding | 4 weeks and 12 months | Variceal bleeding will be assessed every 4 weeks |
Countries
India
Contacts
Primary ContactSubrat K Acharya, DM
Backup ContactShalimar ., DM
Outcome results
None listed