E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C Genotype 1 patients |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008912 |
E.1.2 | Term | Chronic hepatitis C |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 demonstrate that in chronic hepatitis C Genotype 1 patients with previous non-response to peg-IFNα2a/RBV or with previous relapse after peg-IFNα2a/RBV treatment triple therapy with DEB025 leads to a superior cEVR (by Limit of Quantification, LOQ, i.e. HCV RNA < 25 IU/mL) rate as compared to peg-IFN/RBV |
|
E.2.2 | Secondary objectives of the trial |
To demonstrate that triple therapy with DEB025 plus peg-IFNα2a/RBV variable treatment duration followed by peg-IFN/RBV to complete a total treatment duration of 48 weeks leads to a superior SVR12 (HCV RNA < LOQ at the end of 12 week post-treatment follow-up) rate as compared to peg-IFN/RBV for 48 weeks |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Chronic hepatitis C G1 viral infection Plasma HCV RNA level lower limit ≥ 1,000 IU/ml assessed by qPCR (quantitative polymerase chain reaction) or equivalent at screening; no upper limit; HCV genotype 1; Previous non-responders/ relapsers to SOC after treatment for at least 12 weeks.
other inclusion criteria may apply
|
|
E.4 | Principal exclusion criteria |
Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, UNLESS they are using a highly effective contraception.
other exclusion criteria may apply |
|
E.5 End points |
E.5.1 | Primary end point(s) |
cEVR (complete early virologic response) i.e. HCV RNA < 25 IU/mL (by Limit of Quantitation, LOQ)
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
SVR12: sustained virologic response 12 weeks following cessation of therapy, defined as HCV RNA negative (by LOQ)
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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.8.2.4 | Number of treatment arms in the trial | 4 |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 |
Australia |
Belgium |
France |
Germany |
Hungary |
Italy |
Poland |
Romania |
Spain |
Taiwan |
Turkey |
United Kingdom |
United States |
|
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
|
Last visit of the last subject undergoing the trial (SVR 24) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
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 | 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 |