Randomised study for immunosuppression regimen in liver transplantatio

Completed

Conditions: Hepatitis C virus (HCV)-induced cirrhosis
Digestive System
Fibrosis and cirrhosis of liver

Registration Number: ISRCTN94834276

Lead Sponsor: Royal Free Hampstead NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 110

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

1. Retransplantation
2. Multi-organ, split or auxiliary transplants
3. Contraindications to tacrolimus or azathioprine
4. Refusal to participate

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary end-point was whichever of the following occurred first:<br>1. Progression of fibrosis, to Ishak stage 4, or <br>2. Graft failure requiring retransplantation or patient death, or <br>3. Treatment failure for immunological reasons, i.e., more than two histologically confirmed episodes of cellular rejection failing to respond to therapy<br><br>The primary endpoints were measured either in yearly intervals (biopsies) or whenever they occurred within the study period.

Secondary Outcome Measures

Name	Time	Method
Secondary end-points included:<br>1. Patient survival<br>2. Acute cellular rejection early (less than 14 days) or not<br>3. Chronic rejection<br>4. Steroid resistant cellular rejection irrespective of further changes in immunosuppression<br>5. Recurrence of HCV, defined by Ishak inflammation score greater than or equal to 4 <br>6. Withdrawal from the randomised allocation<br><br>The secondary endpoints were measured at yearly endpoints or whenever a clinical decompensation occurred.