Hepatitis C virus (HCV)-induced cirrhosis Digestive System Fibrosis and cirrhosis of liver
Conditions
Interventions
Tacrolimus (Prograf®, Fujisawa Ltd, Ireland) 0.1 mg/kg/day was given in two divided doses in both MT and TT groups starting within 6 hours from transplantation via a nasogastric tube. Azathioprine was
Sponsors
Royal Free Hampstead NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: From January 2000 to June 2007, in three liver transplant centres, (Royal Free Hospital, Edinburgh Royal Infirmary and St Vincents Hospital, Dublin; all using the same donor pool) consecutive transplant recipients were randomised if they: 1. Had cirrhosis 2. Were hepatitis C virus ribonucleic acid (HCV RNA) positive in serum 3. Had previous histology confirming HCV-related disease 4. Had possible or confirmed/concomitant alcoholic aetiology or hepatocellular carcinoma (HCC) 5. Were older than 18 years, either sex 6. Had given informed written consent (at listing for transplantation) 7. Received a cadaveric liver transplant
Exclusion criteria
Exclusion criteria: 1. Retransplantation 2. Multi-organ, split or auxiliary transplants 3. Contraindications to tacrolimus or azathioprine 4. Refusal to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end-point was whichever of the following occurred first: 1. Progression of fibrosis, to Ishak stage 4, or 2. Graft failure requiring retransplantation or patient death, or 3. Treatment failure for immunological reasons, i.e., more than two histologically confirmed episodes of cellular rejection failing to respond to therapy The primary endpoints were measured either in yearly intervals (biopsies) or whenever they occurred within the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end-points included: 1. Patient survival 2. Acute cellular rejection early (less than 14 days) or not 3. Chronic rejection 4. Steroid resistant cellular rejection irrespective of further changes in immunosuppression 5. Recurrence of HCV, defined by Ishak inflammation score greater than or equal to 4 6. Withdrawal from the randomised allocation The secondary endpoints were measured at yearly endpoints or whenever a clinical decompensation occurred. | — |
Countries
Ireland, United Kingdom
Outcome results
None listed