E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic hepatitis C infection |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic hepatitis C infection |
|
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 | 16.0 |
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 | 100000004848 |
|
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 is to assess the antiviral efficacy of telaprevir,
Peg-IFN-alfa-2a, and RBV in HCV-1/HIV-1 coinfected subjects as
measured by sustained virologic response (SVR12planned).
SVR12planned is defined as having HCV RNA levels < 25 IU/mL 12
weeks after the last planned dose of HCV study medication. |
|
E.2.2 | Secondary objectives of the trial |
Reference is made to section 2.1 (p.39 - 40) of the Clinical Trial Protocol. |
|
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 |
A substudy of VX-950HPC3008 to evaluate the intensive steady-state pharmacokinetic profile of telaprevir and selected antiretrovirals |
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E.3 | Principal inclusion criteria |
- Chronic (detectable hepatitis C virus (HCV) ribonucleic acid (RNA) more than 6 months prior screening or histological diagnosis based on liver biopsy or fibroscan) HCV infection genotype 1 with HCV RNA level greater than 1,000 IU/mL
- Confirmed diagnosis of Human immunodeficiency virus-1 (HIV-1) infection more than than 6 months before the screening visit
- Cluster of differentiation 4 (CD4) count greater than 300 cells/mm3 at screening and no value less than 200 cells/mm3 within 6 months of screening visit
- HIV-1 RNA less than 50 copies/mL or patient must have HIV-1 RNA undetectable by a local specific HIV RNA test data at least once within 6 months of prior to the screening visit
- No HIV RNA values greater than 200 copies/mL within 6 months of the screening visit (or not greater than the lower limit of detection for assays with a limit of 500 copies/mL)
- Currently taking one of the permitted anti- HIV regimens for greater than or equal to12 weeks |
|
E.4 | Principal exclusion criteria |
- Anticipated need to switch anti-HIV regimen from screening through the Telaprevir treatment period through Week 14
- Infection or co-infection with HCV other than genotype 1
- Contraindication to the administration of Peg-IFN-alfa or RBV
- Hepatitis B virus (HBV) co-infection
- Acute or active condition of HIV-associated opportunistic infection within 6 months of screening |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Number of patients achieving sustained virologic response (SVR)
12 planned |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Number of patients achieving SVR12 defined as undetectable
- Number of patients achieving SVR24 planned
- Number of patients achieving SVR24 defined as undetectable
- Number of patients achieving undetectable HCV RNA levels at Week 4
- Number of patients achieving undetectable HCV RNA levels at Week 12
- Number of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 (eRVR)
- Number of patients achieving undetectable HCV RNA at the actual end of treatment
- Number of patients achieving undetectable HCV RNA at the planned end of treatment
- Number of patients achieving HCV RNA less than 25 IU/mL at the planned end of treatment
- Number of patients with ontreatment virologic failure
- Number of patients with relapse during the follow-up period after previous undetectable HCV RNA at actual end of treatment
- Number of patients with relapse during the follow-up period after previous undetectable HCV RNA at planned end of treatment
- Number of patients with relapse during follow up period after previous HCV RNA less than 25 IU/mL at planned end of treatment
- Number of patients with viral breakthrough
- Change from baseline in log HCV RNA values
- Number of patients with adverse events |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Week 60
- Week 72
- Week 72
- Week 4
- Week 12
- Week 4 and Week 12
- Week 24, Week 48, early discontinuation
- Week 24, Week 48
- Week 24, Week 48
- Through Week 72
- Week 72
- Week 72
- Week 72
- Through Week 72
- Through Week 72
- Up to Week 72 |
|
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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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.8.3 |
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 | 22 |
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 |
Brazil |
France |
Poland |
Russian Federation |
Spain |
Sweden |
United Kingdom |
|
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 | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |