E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic hepatitis C virus genotype 5 or 6 infection, cirrhosis |
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E.1.1.1 | Medical condition in easily understood language |
Chronic hepatitis C infection, cirrhosis |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019752 |
E.1.2 | Term | Hepatitis C virus (HCV) |
E.1.2 | System Organ Class | 100000074171 |
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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 assess the efficacy by evaluating the percentage of subjects achieving a 12-week post-treatment sustained virologic failure response (SVR12) in combined treatment arms and safety of treatment with the Glecaprevir/Pibrentasvir combination regimen in adults with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection with and without cirrhosis. |
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E.2.2 | Secondary objectives of the trial |
To assess the percentage of subjects with HCV on-treatment virologic failure, and the percentage of subjects with HCV virologic relapse in combined treatment arms. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, at least 18 years of age at time of Screening.
2. Screening laboratory result indicating HCV GT5 or 6 infection.
3. Subject has a positive anti-HCV Ab and plasma HCV RNA ≥ 1000 IU/mL at Screening Visit.
4. Subject must be HCV treatment-naïve (i.e., has never received a single dose of any approved or investigational anti-HCV medication) or treatment-experienced (i.e., has failed prior interferon [IFN] or pegylated interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN therapy). Prior HCV treatment with any other approved or investigational medications is not allowed. Previous HCV treatment must have been completed ≥ 2 months prior to screening.
5. Subject must be documented as having no cirrhosis or compensated cirrhosis (as described in Section 5.3.1.1) non-cirrhotic or cirrhotic. |
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E.4 | Principal exclusion criteria |
1. History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.
2. Female subject who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
5. HCV genotype performed during screening indicating co-infection with more than one HCV genotype. |
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E.5 End points |
E.5.1 | Primary end point(s) |
SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug) within each genotype (GT5 and GT6 subjects) separately across treatment arms. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after last dose of study drug |
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E.5.2 | Secondary end point(s) |
The percentage of subjects with on-treatment HCV virologic failure and the percentage of subjects with post-treatment HCV virologic relapse within each genotype (GT5 and GT6 subjects) separately, across treatment arms. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) During treatment and at the end of treatment with at least 6 weeks of treatment. 2) At the end of treatment and 12 weeks after last dose of treatment. |
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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 | 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 | 2 |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
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 | No |
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 |
Canada |
New Zealand |
Singapore |
South Africa |
United States |
Vietnam |
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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
| |
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 | 4 |
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 | 4 |