E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C Genotype 1 patients |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 11 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008912 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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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 whether the proportion of patients who achieve cEVR (by Limit of Quantitation, LOQ, i.e. HCV RNA < 25 IU/mL) after 12 weeks of triple therapy with DEB025 600 mg/day combined with peg-IFNα2a 180 µg 1x/week and RBV 1000/1200 mg/day is higher compared to the proportion of patients who achieve cEVR after 12 weeks of placebo matching DEB025 treatment plus SOC therapy consisting of peg-IFNα2a 180 µg 1x/week + RBV 1000/1200 mg/day in chronic hepatitis C GT1 patients with previous non-response to SOC. |
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E.2.2 | Secondary objectives of the trial |
The key secondary efficacy variable is the proportion of patients who achieve SVR24, defined as HCV RNA < LOQ at the end of 24 week post-treatment follow-up. The key secondary comparison is between active DEB025 600 mg plus SOC treatment group (A) and DEB025 600 mg placebo plus SOC control group (C) in terms of proportion of patients achieving SVR24.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients eligible for inclusion in this study have to fulfill all of the following criteria: 2. Written informed consent must be obtained before any assessment is performed. 3. Males or females aged ≥18 and ≤ 65 years; 4. BMI between ≥ 18 and ≤ 36 kg/m2; 5. HBsAg negative and HIV negative; 6. Chronic hepatitis C viral infection on record and diagnosed by two tests performed at an interval of at least 6 months (the initial diagnosis can be based on positive HCV antibodies or quantitative or qualitative HCV RNA measurement). Furthermore, chronicity needs to be confirmed by a positive HCV RNA test, i.e. qPCR (quantitative polymerase chain reaction); thus the 2nd test may be performed at screening; 7. Plasma HCV RNA level lower limit ≥ 10000 IU/ml assessed by qPCR (quantitative polymerase chain reaction) or equivalent at screening; no upper limit; 8. HCV genotype 1; 9. Previous non-responders to SOC (with peg-IFNa 2a or 2b and RBV) after full dose treatment for at least 12 weeks with detectable HCV RNA at the end of treatment. A minimum of 3 months must have elapsed since the patient's last treatment when the patient qualified as a non-responder and recruitment into this study.
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E.4 | Principal exclusion criteria |
•Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening in this trial. •Ongoing or recent use of any other medication which are known inhibitors/inducers of cytochrome 450 3A, substrates of cytochrome 450 3A, substrates of P-gp, or substrates/inhibitors of OATPs, MRP2 or BSEP (list of unauthorized medications). •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. Any medical contraindication to treatment with IFN and/or RBV. •Patients with evidence of cirrhosis at the time of screening.
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving cEVR (by Limit of Quantitation, LOQ, i.e. HCV RNA <25 IU/mL) after 12 weeks |
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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 | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 46 |
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 | Yes |
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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Last visit of the last subject undergoing the trial (SVR 24) |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 15 |