Health Condition 1: K00-K95- Diseases of the digestive system Health Condition 2: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Obeticholic acid: Obeticholic acid 5mg - 10mg per day
Control Intervention1: Ursodeoxycholic acid: Ursodeoxycholic acid 10-15mg/kg per day
Sponsors
Amrita Institute of Medical Sciences and Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.All adult patients undergoing live donor liver transplantation.
Exclusion criteria
Exclusion criteria: 1.Recipients less than 18 years of age 2.Deceased donor liver transplants 3.ABO-incompatible transplants 4.Recipients who did not survive beyond 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary composite endpoint is a 15% reduction of alkaline phosphatase and gamma-glutamyl transferase from baseline (one month post liver transplantation).Timepoint: One month post transplantation (baseline), 3 months, 6 months, 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Biopsy proven Acute or Chronic rejection 2.Incidence of biliary complications 3.All-cause mortality 4.Any adverse events 5.Death due to acute or chronic rejection 6.Quality of life 7.Incremental cost analysis Timepoint: 1.Quality of life: Base line and 12 th month 2.Incremental cost analysis:Base line and 12 th month. 3.All other outcomes measured through out study period. | — |
Countries
India
Contacts
Public ContactDrSudhindran S
Amrita Institute of Medical Sciences and Research Centre
Outcome results
None listed