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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ribavirin | Active Comparator | 1000 mg (5 capsules) |
|
| Placebo | Placebo Comparator | 5 capsules of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribavirin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in survival | 4 weeks and 12 moths |
| Measure | Description | Time Frame |
|---|---|---|
| Child Score | Change in Child Score will be evaluated at every 4 week interval | 4 weeks and 12 months |
| Viremia | Change in viral load | 4 weeks, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Subrat K Acharya, DM | Contact | +91-11-26594934 | subratacharya2004@yahoo.com | |
| Shalimar ., DM | Contact | +919968405815 |
| Name | Affiliation | Role |
|---|---|---|
| Subrat K Acharya, DM | All India Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AII India Institute of Medical Sciences | Recruiting | Delhi | National Capital Territory of Delhi | 110029 | India |
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
| Variceal bleeding | Variceal bleeding will be assessed every 4 weeks | 4 weeks and 12 months |
| All India Institute of Medical Sciences | Recruiting | Delhi | National Capital Territory of Delhi | 110029 | India |
|