Patients who have undergone liver transplantation and are infected with Hepatitis C virus. MedDRA version: 9.1 Level: HLT Classification code 10052779 Term: Transplant rejections MedDRA version: 9.1 Level: HLGT Classification code 10024970 Term: Respiratory tract infections MedDRA version: 9.1 Level: HLT Classification
Conditions
Interventions
Trade Name: Rapamune
Pharmaceutical Form: Coated tablet
INN or Proposed INN: SIROLIMUS
CAS Number: 53123889
Trade Name: Prograf
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Adults only (18-70) 2)Who have undergone liver transplantation (as a single organ graft) 3)With Hepatitis C virus infection within the graft 4)Patients with established fibrosis 5)Patients on Calcineurin Inhibitor monotherapy 6)Patients would be a minimum of 12 months post transplant 7)Patients should have adequate stable renal function defined as GFR >40ml/min and 24 hour protein excretion =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1)Multi-organ transplant recipients 2)Pregnancy 3)Co-infection with Hepatitis B 4)Co-infection with HIV or HTLV-1 5)Where there is thought to be high risk of hepatocellular carcinoma in the recipient liver 6)Patients with moderate to severe renal impairment (defined above) 7)Patients who have received anti-viral therapy in the 6 months prior to biopsy 8)Patients who have had an episode of acute rejection in past 6 months 9)Patients who require immunosuppression with more than 1 agent 10)Patients with severe diarrhoea 11)Neutropenia (defined as neutrophil count4.5 mmmol/l or total cholesterol >7.5 mmol/l.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We believe that patients who have had a liver transplant and are infected with Hepatitis C will develop less scarring (fibrosis) in their transplant liver if their anti-rejection (immunosuppressant)medication is switched from a calcineurin inhibitor (current standard therapy) to Sirolimus. This trial will test this hypothesis.;Secondary Objective: We would also like to see if there was any benefit to patients' kidney function, blood pressure, blood glucose, and whether there were improvements in patient's cardiovascular risk categorized by blood lipid and uric acid levels and glucose tolerance and cardiovascular events during the trial period.;Primary end point(s): The primary endpoint is change in fibrosis stage over the study period. | — |
Countries
United Kingdom
Outcome results
None listed