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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
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 |
To compare rates of SVR12 for Genotype 4 subjects treated with either BMS-790052 or placebo in combination with pegIFNα-2a/RBV. |
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E.2.2 | Secondary objectives of the trial |
• To assess efficacy, as determined by:
− HCV RNA < LOQ at each of the following time points: Weeks 1, 2, 4, 6, 8, and 12; at both Weeks 4 and 12 VR(4&12); EOT (up to 48 weeks); post-treatment Week 24 (SVR24); or post-treatment Week 48 for subjects who achieve VR(4&12);
− HCV RNA undetectable at each of the following time points: Weeks 1, 2, 4, 6, 8, and 12; at both Weeks 4 and 12 VR(4&12); EOT (up to 48 weeks); post-treatment Week 12; post-treatment Week 24; or post-treatment Week 48 for subjects who achieve VR(4&12).
• To assess on treatment safety, as measured by the frequency of
Serious Adverse Events (SAEs) and discontinuations due to AEs.
• To assess the relationship between efficacy endpoints and the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subjects chronically infected with HCV Genotype 4
• HCV RNA viral load of ≥ 10,000 IU/mL
• No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent (DAA).
• Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Subjects with compensated cirrhosis are permitted, however, and any prior biopsy is permitted.
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E.4 | Principal exclusion criteria |
• Evidence of decompensated liver disease
• Documented or suspected HCC
• Positive for HBsAg or HIV-1/HIV-2 antibody at screening
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare rates of SVR12 for subjects treated with either BMS-790052 or placebo in combination with pegIFNα-2a/RBV. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) Proportion of subjects who achieve HCV Ribonucleic acid (RNA) < Limit of quantification (LOQ)
2) Proportion of subjects who achieve HCV RNA undetectable
3) Frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) for all subjects on treatment
4) Proportion of subjects with SVR12 or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Weeks 1, 2, 4, 6, 8 and 12; at both weeks 4 and 12; EOT (up to 48 weeks); post-treatment week 24 (SVR24); or post-treatment Week 48 for subjects who achieve Virologic response at week 4 and week 12 [VR(4&12)] defined as HCV RNA undetectable at weeks 4 and 12
2) Weeks 1, 2, 4, 6, 8, and 12; at both weeks 4 and 12 (VR4&12); EOT; post-treatment week 12; post-treatment week 24; or post-treatment Week 48 for subjects who achieve VR(4&12)
3) Maximum of 48 weeks
4) Post-treatment week 12 and post treatment week 24 |
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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 | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
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 |
Argentina |
Brazil |
Canada |
France |
Italy |
Mexico |
New Zealand |
Puerto Rico |
Russian Federation |
Spain |
Turkey |
United Kingdom |
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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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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |