E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic hepatitis C infection |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008912 |
E.1.2 | Term | Chronic hepatitis C |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To evaluate the number of patients achieving RVR, cRVR and SVR. - To evaluate compliance to PEG-INF, RBV and erytropoetin treatment |
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E.2.2 | Secondary objectives of the trial |
To study if and how the early HCV RNA kinetics (week 1, 2, 3, 4 and 8) and viral decline rate (second phase slope) can promote an early identification of patients with non-response who should discontinue treatment, as well as patients likely to relapse who may need prolonged treatment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• signed written informed consent • transplanted patients with histological proven hepatitis C relaps irrespective of response to a prior therapy before transplantation or whether untreated before transplantation • Male and female patients transplanted for end stage cirrhosis caused by hepatitis C virus with or without HCC >18 years of age with any genotype are eligible • A positive HCV RNA test in serum • Liver biopsy findings consistent with a histological relapse of hepatitis C on a protocol biopsy after liver transplantation with Fibrosis stage 1-3 • Compensated liver disease • Negative urine pregnancy test (for women of childbearing potential) • All fertile males and females must be using effective contraception during treatment and during the 6 months after treatment end • If possible immunosuppressive treatment should not include MMF or azathioprine
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E.4 | Principal exclusion criteria |
• Liver biopsy findings consistent with firmly established cirrhosis (fibrosis grade IV) or clinical evidence of cirrhosis • Patients with signs of moderate – severe rejection (RAI score >=6) on the protocol biopsy which should be properly treated before the patients can be included • Any investigational drug (other than study drugs) <=6 weeks prior to the first dose of study drug • Adverse reaction to erythropoietin or other components of NeoRecormon® or Aranesp • Co-infection with hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV) • Significant chronic liver disease other than HCV • Hepatocellular carcinoma in the new liver transplant • Decompensated liver disease • Neutrophil count <1.5 x 10 (9) /L or platelet count <90 x 10 (9) /L at screening • Creatinine clearance < 50 ml/min at screening • Severe psychiatric disease, especially depression. • Seizure disorders • Other severe chronic illnesses that could constitute a medical risk • Thyroid disease poorly controlled on prescribed medications • Drug abuse (including excessive alcohol consumption) within one year of study entry • Hgb <115 g/L in women or <120 g/L in men at screening • Patients with coronary artery disease or cerebrovascular disease should not be enrolled if a decrease in hemoglobin by up to 30 g/L would not be tolerated • Uncontrolled hypertension • Adverse reaction to erythropoietin or other components of NeoRecormon® • History or evidence of risk of thrombosis • Thrombocytosis, platelets >500 000/mm3
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of patients achieving sustained virological response defined as HCV-RNA negative 6 months after end of treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |