E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
viral hepatitis C |
Hépatite virale chronique C de génotype 1b/ Patients ayant une fibrose hépatique faible |
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E.1.1.1 | Medical condition in easily understood language |
viral hepatitis C |
hépatite C |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
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 |
The primary objectives of this study are as follows:
• To evaluate the efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).
• To evaluate the safety and tolerability of EBV/GZR treatment
|
Evaluer l’efficacité de l’association à dose fixe d’Elbasvir/Grazoprevir pendant 8 semaines chez des patients hépatite C, naïfs de traitement, génotype 1b, sans fibrose sévère en fonction de la réponse virale soutenue 12 semaines après la fin du traitement (SVR12 ) ; Evaluer l’innocuité et la tolérance du traitement Elbasvir/Grazoprevir |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are as follows:
• To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24)
• To evaluate the proportion of subjects with virologic failure
• To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment.
• To evaluate the emergence of viral resistance to EBV/GZR during treatment and after cessation of treatment
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Déterminer la proportion de sujets avec une réponse virale 4 et 24 semaines après la fin du traitement (SVR4 et SVR24). Evaluer la proportion de sujets en échec de réponse virologique. Evaluer la cinétique de l’ARN circulant du virus de l’hépatite C pendant le traitement et le suivi post traitement. Evaluer l’émergence de résistances virales dues à l’association Elbasvir/Grazoprevir pendant le traitement et le suivi post traitement |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1 - Willing and able to provide written informed consent
2 - Male or female, age ≥ 18 years
3 - Body Mass Index (BMI) ≥ 18 kg/m2
4 - HCV RNA ≥ 104 IU/mL at Screening
5- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy. Only patients infected by genotype 1b virus will be included.
6 - Treatment-naïve with no prior exposure to any IFN, RBV, or approved or experimental HCV-specific DAA
7 – Non severe fibrosis (F < 2) according to Metavir score if a biopsy was performed or elasticity measured by Fibroscan® lower than 9.5 kPa or Fibrotest lower than 0.59 or Fibrometre lower than 0.63 if Fibroscan® cannot be performed.
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1 – signature du consentement libre et éclairé
2 – Adulte de plus de 18 ans
3 – Indice de masse corporelle ≥ 18 kg/m2
4 – Charge virale VHC ≥ 104 IU/mL au screening
5 - Hépatite chronique C détectée depuis plus de 6 mois, avec un génotype 1b
6 – Patient naïf de tout traitement anti-VHC
7 – Fibrose minime à modérée (F < 2) selon score Métavir soit par biopsie hépatique, ou Fibroscan® inférieur à 9.5 kPa ou Fibrotest® inférieur à 0.59 ou Fibrometre® inférieur à 0.63
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E.4 | Principal exclusion criteria |
1 - Medical histaru with significant event
2- Significant abnormal lab results at screening
3 - Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, alfa-1 antitrypsin deficiency, cholangitis)
4 - Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
5 - Clinically-relevant alcohol or drug abuse within 12 months of Screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator
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1 - Historique médical avec évènements significatifs
2 - Résultats de laboratoire hors normes au screening
3 – Maladie chronique du foie hors hépatite C (ex : Hemochromatose, Maladie de Wilson, Déficit en alpha-1 antitripsine, cholangiome…)
4 – Coinfection par le virus de l’hépatite B (VHB) ou le HIV
5 – Consommation excessive d’alcool ou de drogue dans les 12 mois précédent le screening.
6 – Utilisation de médicaments contre-indiqués ou interdits
7 – Hypersensibilité ou allergie connue à un principe actif, un composant ou un excipient présent dans le traitement
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E.5 End points |
E.5.1 | Primary end point(s) |
Sustained virologic response |
réponse virale soutenue (SVR) ≥ à 96 % à 12 semaines après l’arrêt du traitement par un dosage de l’ARN circulant du VHC |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after end of treatment |
12 semaines après l’arrêt du traitement |
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E.5.2 | Secondary end point(s) |
• To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24)
• To evaluate the proportion of subjects with virologic failure
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|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
4 and 24 weeks after cessation of treatment |
|
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 | 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 | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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last visit of the last subject |
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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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |