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 | 15.1 |
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 | 100000004848 |
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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 based on the proportion of subjects with SVR12, defined as HCV RNA<LOQ at follow-up Week 12, for all subjects infected with HCV genotype 1 who are prior non-responders to pegIFNα-2a/RBV. |
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E.2.2 | Secondary objectives of the trial |
• To assess efficacy, as determined by the proportion of subjects with
SVR12 for HCV genotype 2, 3, and 4 prior non-responders to pegIFNα-2a/RBV and treatment naive HCV genotype 1b;
• To assess safety, as measured by the frequency of SAEs and discontinuations due toAEs for each treatment regimen;
• To assess efficacy, as determined by the proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) at weeks: 1, 2, 4,6, 8 and 12; Weeks 4 and 12 [VR (4&12)], EOT, or follow-up Week 24 (SVR24) for each HCV genotype and treatment regimen;
• To assess efficacy, as determined by the proportion of subjects who achieve HCV RNA undetectable at weeks: 1, 2, 4, 6, 8 and 12; Weeks 4 and 12 (eRVR), EOT, follow-up Week 12, or follow-up Week 24 for each HCV genotype and treatment regimen;
• To describe drug-resistant variants associated with virologic failure for
each HCVgenotype and treatment regimen.
See Protocol section 1.3.3 for additional exploratory objectives. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Prior participation in any BMS-790052, BMS-650032, BMS-791325 trial
and assigned to control arm during the trial.
• HCV genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
• HCV RNA viral load detectable |
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E.4 | Principal exclusion criteria |
• Discontinuation from prior BMS HCV clinical trial due to a peginterferon/ribavirin-related event
• Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052 or BMS-791325;
• Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening;
• Evidence of medical condition associated with chronic liver disease other than HCV;
• Evidence of decompensated cirrhosis based on radiologic criteria or biopsy |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects with SVR12, defined as HCV RNA<LOQ at followup Week 12, for all subjects infected with HCV genotype 1 who are prior non-responders to 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) |
• Proportion of subjects with SVR12, defined as HCV RNA<LOQ at followup
Week 12, for each HCV genotype other than genotype 1 prior nonresponders
to pegIFNα-2a/RBV and treatment naive HCV genotype 1b;
• Frequency of SAEs and discontinuations due to AEs;
• Proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) at weeks: 1, 2, 4, 6, 8 and 12; Weeks 4 and 12 [VR (4 &12)], EOT, or follow-up Week 24 (SVR24) for each HCV genotype and
treatment regimen;
• Proportion of subjects who achieve HCV RNA undetectable at Weeks:
1, 2, 4, 6, 8,and 12, Weeks 4 and 12 (eRVR), EOT, follow-up Week 12 , or
follow-up Week 24 for each HCV genotype and treatment regimen;
• Frequency of genotypic substitutions associated with virologic failure
for each HCV genotype and treatment regimen.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Follow-up Week 12
2) Duration of trial
3) Weeks 1, 2, 4, 6, 8, 12, 24, followup week 12 & 24
4) End of Trial |
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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 | No |
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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
HCV Resistance Testing; Exploratory Biomarker Assessments |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
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 |
Australia |
Austria |
Canada |
Denmark |
France |
Germany |
Greece |
Ireland |
Israel |
Italy |
Korea, Republic of |
Mexico |
Netherlands |
Poland |
Puerto Rico |
Russian Federation |
Spain |
Sweden |
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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The last visit is defined as the follow-up week 24 visit. The end of the study is defined by when the last subject has completed the follow-up week 24 visit, was lost to follow-up, or discontinues from the study. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
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 |