E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C genotype 1 treatment-naïve patients |
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E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C genotype 1 treatment-naïve patients |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
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 |
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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 |
The primary objective is to demonstrate that the proportion of treatment-naive hepatitis C patients who achieve SVR24 is superior in patients treated with triple therapy (DEB025 + peg-INF2alfa + Ribavirin) compared to patients treated with dual therapy (peg-INF2alfa + Ribavirin).
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E.2.2 | Secondary objectives of the trial |
The key secondary objective is to explore whether a shorter durations of triple therapy treatment (24 weeks), guided by on-treatment responses, can result in a similar SVR24 rate to that achieved by triple therapy over 48 weeks.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Chronic hepatitis C viral
-HCV genotype
-no previous treatment for hepatitis C infection
-Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit.
-liver evaluation prior to Baseline: liver biopsy within 3 years or Fibroscan within 6 months. |
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E.4 | Principal exclusion criteria |
Key exclusion criteria are :
-HCV genotype different from genotype 1 or co-infection with other HCV genotype.
-co-infection with Hepatitis B or HIV
-Any other cause of relevant liver disease other than HCV
-Presence or history of hepatic decompensation
-ALT ≥ 10 times ULN,
- more than 1 episode of elevated bilirubin (>ULN) in past 6 months
Other protocol-defined inclusion/exclusion criteria may apply |
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E.5 End points |
E.5.1 | Primary end point(s) |
Sustained Viral Response Week 24 (SVR 24) defined as serum HCV RNA undetectable by limit of detection (LOD) 24 weeks after treatment completion |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 weeks after treatment completion |
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E.5.2 | Secondary end point(s) |
1) Rapid Virological response by limit of detection (RVR4LOD), Rapid Virological response by limit of quantification (RVR4LOQ) – defined as serum HCV RNA below LOD or LOQ respectively after 4 weeks of treatment
2)-Early Virological Response (EVR): serum HCV RNA reduction by at least 2Log10 or serum HCV RNA below LOQ 12 weeks after treatment start
-partial Early Virological Response (pEVR): serum HCV RNA reduction by at least 2Log10 but still detectable 12 weeks after treatment start
-complete Virological Response (cEVR): serum HCV RNA below LOD 12 weeks after treatment start
-eRVRLOD: RVR4LOD achieved and maintained 12 weeks after treatment start
-eRVRLOQ: RVR4LOQ achieved and maintained 12 weeks after treatment start
3)-End of treatment response (ETR) – defined as HCV RNA undetectable by limit of detection,
-Sustained Virological Response Week 12 (SVR12) defined as serum HCV RNA undetectable by limit of detection (LOD) 12 weeks after treatment completion
- Sustained Virological Response Week 48 (SVR48) defined as serum HCV RNA undetectable by limit of detection (LOD) 48 weeks after treatment completion
4)Change in liver enzyme (ALT and bilirubin) and hematological patient profiles (platelets, neutrophils, hemoglobin) during treatment phase. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1)4 weeks after treatment start
2)12 weeks after treatment start
3)at treatment completion whenever it occurs, 12 and 48 weeks after treatment completion
4)48 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 | No |
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) | 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 | 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
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
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 | 65 |
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 |
Argentina |
Australia |
Belgium |
Brazil |
Canada |
France |
Germany |
Hong Kong |
Hungary |
Italy |
Korea, Democratic People's Republic of |
Mexico |
Poland |
Romania |
Russian Federation |
Spain |
Taiwan |
Thailand |
Turkey |
United Kingdom |
United States |
Vietnam |
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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 (SVR24 time point of the last patient in the open label treatment from arm D) |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 15 |