E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 objective of this study is to demonstrate the efficacy of 8-week treatment with GLE/PIB in adults and adolescents with confirmed acute HCV infection by comparing the SVR12 rate from this study to the historical SVR12rate in subjects with chronic HCV infection who were treated with GLE/PIB. The primary efficacy objective will be assessed based on the ITT population which is defined as all enrolled subjects who received at least 1 dose of study drug.
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E.2.2 | Secondary objectives of the trial |
The key secondary objective of this study is the same as the primary objective of this study except that the key secondary objective will be assessed in the modified ITT – virologic failure (mITT-VF) population. The mITT-VF population is defined as all enrolled subjects who received at least one dose of study drug, excluding those who did not achieve SVR12for reasons other than virologic failure (i.e., those with HCV reinfection, those who did not achieve SVR12due to early premature discontinuation of study drug, and those who were missing HCV RNA data in the SVR12window after backward imputation). The other secondary objectives of this study are to determine the on-treatment virologic failure, post-treatment relapse, and post-treatment reinfection rates in the ITT population. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adult or adolescent, age 12 years and older - Subject must have evidence of acute HCV infection prior to enrollment. Evidence of acute HCV infection is defined as physician diagnosis of acute HCV infection, quantifiable HCV RNA at screening and at least 1 of the following: - Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 8-month period prior to Screening OR Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 11-month period prior to Screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen OR Clinical signs and symptoms compatible with acute hepatitis (ALT > 5 × ULN and/or jaundice) in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive HCV RNA or HCV core antigen all within an 8-month period prior to Screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen OR Negative anti-HCV antibody with a positive HCV RNA or HCV core antigen within a 5-month period prior to Screening. - Subject must be HCV treatment-naïve, defined as no prior treatment including interferon for this HCV infection. - Subject must be documented as either having no cirrhosis or as having compensated cirrhosis. If liver diagnostic tests are indeterminate with available diagnostic methods, subject must demonstrate absence of decompensated cirrhosis by evaluating Child-Pugh score. - Absence of hepatocellular carcinoma (HCC) for subjects with cirrhosis or with indeterminate cirrhosis status, as indicated by a negative ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative ultrasound at Screening. Subject who has a positive ultrasound result suspicious of HCC followed by a subsequent negative CT scan or MRI or biopsy result will be eligible for the study. - No history of liver decompensation
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E.4 | Principal exclusion criteria |
- Evidence of chronic HCV infection for this HCV infection. - Subject has a history of severe life-threatening or other significant sensitivity to any excipients of the study drug. - Subject has cause of liver disease other than HCV infection - Subject has uncontrolled drug use that may impair protocol compliance in the opinion of the investigator. - Female who is pregnant or breastfeeding; or is considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug. - Subject must require chronic use of systemic immunosuppressants during the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the achievement of SVR12(defined as HCV RNA < the lower limit of quantification [LLOQ] 12 weeks after the last actual dose of study drug) for each subject in the ITT population.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Treatment Day 1 to end of treatment; end of treatment to post treatment week 12 |
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E.5.2 | Secondary end point(s) |
The key secondary endpoint is achievement of SVR12for each subject in the mITT-VF population.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Treatment Day 1 to end of treatment; end of treatment to post treatment week 12 |
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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 | 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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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 |
United States |
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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
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The end-of-study is defined as the date of end of study participation by the last subject in the last country where the study was conducted.
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 14 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 8 |