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 | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10072848 |
E.1.2 | Term | Hepatitis C virus genotype 1 positive |
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 demonstrate the effectiveness of Triple fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects |
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E.2.2 | Secondary objectives of the trial |
Only key secondary objectives are listed, for others please refer to the protocol
- To demonstrate the proportion of experienced non-cirrhotic subjects enrolled to Triple FDC with SVR12, defined as HCV RNA < LLOQ target detected or target not detected (LOQ TD/TND) at follow up Week 12 is significantly greater than the historical threshold of 49%;
- To evaluate the proportion of subjects in each cohort who achieve HCV RNA < LOQ TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, and 12; post-treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24);
-To evaluate the proportion of subjects in each cohort who achieve HCV RNA < LOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, and 12; post-treatment Weeks 4, 8, 12 and 24;
- To evaluate on treatment safety, as measured by frequency of SAEs and discontinuations due to AEs through the end of treatment plus in each cohort; |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacogenetics Blood Sample Amendment 01, version 1.0, dated 11-Oct-2013
The objective of this Amendment is to permit the collection and storage of blood samples for use in future exploratory pharmacogenetic research. Bristol-Myers Squibb will use DNA obtained from the blood sample and health information collected from the main clinical trial, AI443102 to study the association between genetic variation and drug response. Bristol-Myers Squibb may also use the DNA to study the causes and further progression of Hepatitis C Samples from this
study may also be used in conjunction with pharmacogenetic research results from other clinical studies to accomplish this objective. |
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E.3 | Principal inclusion criteria |
Key Inclusion Criteria:
•Subjects chronically infected with HCV genotype 1
•HCV RNA ≥ 10,000 IU/mL at screening;
•Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
•Treatment-experienced subjects are eligible including previous exposure to anti-HCV agents of a mechanistic class other than those contained in the DCV/ASV/BMS-791325 triple regimen |
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E.4 | Principal exclusion criteria |
Key Exclusion Criteria:
• Evidence of cirrhosis
• Liver or any other organ transplant
• Current or known history of cancer within 5 years prior to screening
• Documented or suspected HCC,
• Evidence of decompensated liver
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of treated subjects in the naive cohort with SVR12, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND) at post treatment Week 12. |
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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) |
Key secondary endpoints:
- To demonstrate the proportion of experienced non-cirrhotic subjects enrolled to Triple FDC with SVR12, defined as HCV RNA < LLOQ target detected or target not detected (LOQ TD/TND) at follow up Week 12 is significantly greater than the historical threshold of 49%;
- To evaluate the proportion of subjects in each cohort who achieve HCV RNA < LOQ TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, and 12; post-treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24);
-To evaluate the proportion of subjects in each cohort who achieve HCV RNA < LOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, and 12; post-treatment Weeks 4, 8, 12 and 24;
- To evaluate on treatment safety, as measured by frequency of SAEs and discontinuations due to AEs through the end of treatment plus in each cohort; |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
•Post treatment Week 12.
•On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24);
•Weeks: 1, 2, 4, 6, 8, and 12;post treatment weeks 4, 8, 12 and 24;
•On 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Biomarker Assessments, Virologic Resistance Testing, Brief Questionnaire/Interim Phone Contacts |
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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) | 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 | Yes |
E.8.1.7.1 | Other trial design description |
Single group for naive, single group for experienced |
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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 | 6 |
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 | 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 |
France |
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 the study will be considered the last subject’s last visit date, or the date the last data point required for statistical analysis is received from 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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 13 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 13 |