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 Transplantation

Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 0 人开始时间: 2009年4月14日最近更新: 2019年6月30日

适应症

试验速览

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•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

•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.

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