E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 provide treatment or re-treatment with Pegasys as monotherapy or in combination with Copegus, to patients with chronic hepatitis C (CHC) who participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol (‘donor’ protocol). |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- As described in protocol section 2 (Objectives of the study) - Be eligible for treatment or re-treatment as defined in the donor protocol - Have completed safety and efficacy assessments as defined in the donor protocol without violation or major deviation - Have had at least a 6 month washout period from date of last dose from donor protocol NV19865; To ensure a proper balance between risk and benefit, a longer washout period should be considered for patients who experienced lymphopenia for extended periods of time in donor protocol NV19865 - Have not received any other anti-HCV treatment after the completion of the donor protocol - Have a negative pregnancy test (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs. Additionnally, fertile patients (males and females) must use two reliable forms of effective contraception (combined) during the entire period of the study (treatment and follow-up) in accordance with locally approved label for ribavirin (COPEGUS). |
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E.4 | Principal exclusion criteria |
- Females who are pregnant or breast-feeding - Male partners of females who are pregnant - Patients with hemoglobinopathies - Hepatic decompensation (Child-Pugh class B and C) before or during treatment - Neutrophil counts < 1500 cells/mm3, platelet counts < 90000 cells/mm3 or Hgb < 12 g/dL in females or < 13 g/dL in males, lymphocyte counts <1500 cells/mm3 - Non-responder patients (defined as patients previously treated with PEGASYS and COPEGUS combination therapy at standard doses, with greater than or equal to 80% compliance (defined as having taken greater than or equal to 80% of PEGASYS doses, greater than or equal to 80% of COPEGUS doses for greater than or equal to 80% of the time between day of first dose and week 12), for at least 12 weeks and did not achieve at least a 2 log drop from their baseline viral load) - History of: - Severe neuropsychiatric disease, especially depression - Significant or unstable cardiac disease - Inadequately controlled hypothyroidism or hyperthyroidism - Inadequately controlled hyperglycemia, hypoglycemia or diabetes mellitus - Immunologically mediated disease including myositis, inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, interstitial nephritis, rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management - Chronic pulmonary disease associated with functional limitation - Severe retinopathy, optic neuropathy or other serious ocular adverse event - Major organ transplantation with an existing functional graft - History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, Wilson’s disease, alpha1 antitrypsin deficiency, alcoholic liver disease, and toxin exposures) - Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is greater than or equal to 20% within 2 years. Patients with a lesion suspicious for hepatic malignancy on the screening imaging study will only be eligible if the likelihood of carcinoma is less than or equal to 10% following an appropriate evaluation. - History of any systemic anti-neoplastic or immunomodulatory treatments (including steroids given at non-physiologic doses and radiation) - History or other evidence of severe illness or any other conditions (e.g. pancreatitis) which would make the patient, in the opinion of the investigator, unsuitable for the study - Evidence of alcohol and/or drug abuse - Inability or unwillingness to provide informed consent or abide by the requirements of the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | No |
E.6.6 | Pharmacokinetic | No |
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
| Information not present in EudraCT |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
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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The end of the study is defined as last patient last visit. Last patient last visit is the date of the last patient visit of the last patient to complete the study, or the date at which the last data point from the last patient, which was required for statistical analysis (i.e., key safety and efficacy results for decision making), was received, whichever is the later date. |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 9 |