A Multi-Centre Prospective Controlled Trial Comparing Calcineurin Inhibitor Monotherapy With Sirolimus Monotherapy in Hepatitis C Infected Patients with Hepatic Fibrosis Following Liver Transplantation - Sirolimus and Hepatitis C following Liver Transplantatio

Phase 1

• Conditions: 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 code 10046577 Term: Urinary tract infections; MedDRA version: 9.1 Level: LLT Classification code 10001032 Term: Acute pyelonephritis; MedDRA version: 9.1 Level: LLT Classification code 10040072 Term: Septicaemia; MedDRA version: 9.1 Level: HLT Classification code 10019972 Term: Herpes viral infections; MedDRA version: 9.1 Level: HLGT Classification code 10028440 Term: Mycobacterial infectious disorders; MedDRA version: 9.1 Level: HLT Classification code 10015107 Term: Epstein-Barr viral infections; MedDRA version: 9.1 Level: LLT Classification code 10011831 Term: Cytomegalovirus infection

• Registration Number: EUCTR2008-000252-28-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-14
• Study Completion: 2012-07-17
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 <0.5 g/l.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 count<1.0 x 10^9/l), Low platelet count (defined as <40 x 10^9/l), untreated hyperlipidaemia (fasting triglycerides>4.5 mmmol/l or total cholesterol >7.5 mmol/l.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.