E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HCV RNA response to a multivalent IFN (Multiferon 6 MU q.d. + ribavirin standard dosed) in prior non-responders to SOC (peg-IFN + ribavirin) during treatment the initial 12 weeks. Results of HCV RNA decline weeks 4 and 12 with SOC and this new treatment will be compared. |
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MedDRA Classification |
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 see if non-responders to SOC (peg-IFN plus ribavirin (RBV)) in whom the HCV RNA decay during SOC has been measured at baseline and weeks 4 and 12 during treatment will respond to Multiferon in combination with RBV with a more pronounced decay of HCV RNA, and if they can achieve complete or partial early viral response (EVR) treatment week 12. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
10-20 patients earlier treated with peg-IFN alfa-2a 180 mcg q.w. in combination with RBV dosed 1000/1200 mg per day (weight <75/>75 kg) in whom results of HCV RNA quantification at baseline, week 4 and 12 as measured by the TaqMan Roche test (sensitivity 15 IU/mL) are available will be recruited. These patients have a well documented prior treatment but should have failed to achive EVR treatment week 12 during SOC treatment.
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E.4 | Principal exclusion criteria |
Patients with concomitant diseases/conditions which are contraindications for treatment with IFN and ribavirin |
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E.5 End points |
E.5.1 | Primary end point(s) |
The HCV RNA decay at treatment week 4 and 12 compared to that seen earlier in the same patients when they were treated with SOC treatment. This study is an exploratory study. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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.8.1.7.1 | Other trial design description |
Each patient is his/her own control |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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Treatment will end after 14 weeks treatment when the results of the HCV RNA quantification at treatment week 12 are available. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |