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 | 17.1 |
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 |
The primary objectives of this study are to assess the safety and to compare the percentage of subjects achieving a 12-week sustained virologic response, SVR12 (HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment) of co-formulated Ombitasvir/ABT-450/Ritonavir co-administered with RBV for 12 or 16 weeks to a clinically relevant threshold (based on SVR rates for HCV genotype 4-infected subjects treated with pegIFN/RBV) in HCV genotype 4-infected adults with compensated cirrhosis. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to compare SVR12 between the 12- and 16- week treatment arms, to assess the percentage of subjects with on-treatment virologic failure in each treatment arm, and to assess the percentage of subjects experiencing post-treatment relapse within 12 weeks following end of treatment (Relapse12) in each treatment arm. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Subjects must meet one of the following:
* Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR
* Treatment Experienced (Prior null responders, Partial responders or Relapsers to IFN/RBV);
- Chronic HCV genotype 4 infection with cirrhosis.
- Subject has plasma HCV RNA level > 1,000 IU/mL at Screening |
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E.4 | Principal exclusion criteria |
-Positive test result at Screening for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
-Current enrollment in another interventional clinical study, previous enrollment in this study, or previous use of any protease inhibitor, non-nucleoside polymerase inhibitor, or NS5a inhibitor, either investigational or experimental (including previous exposure to ABT-450 or ombitasvir), or receipt of any investigational product within 6 weeks prior to study drug administration
-Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation including ascites, variceal bleeding, or hepatic encephalopathy
-Confirmed presence of hepatocellular carcinoma
-Any cause of liver disease other than chronic HCV infection
-Abnormal laboratory tests. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the percentage of subjects with SVR12. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after last dose of study drugs |
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E.5.2 | Secondary end point(s) |
a) The percentage of subjects with sustained virologic response 12 weeks post treatment in Arm A (12 weeks treatment) compared to Arm B (16 weeks treatment)
b) Percentage of subjects in each treatment arm with on-treatment virologic failure during the Treatment Period
c) Percentage of subjects in each arm with post-treatment relapse |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
a) 12 weeks after last dose of study drug;
b) up to 16 weeks after first dose of study drug
c) within 12 weeks after the last dose of study drug |
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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 | No |
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 |
Study includes a Pharmacogenetic (PG) sub-study which is an optional part of the main clinical study. The optional PG sub-study is available for all subjects who participate in the main study; subjects can choose to participate in the optional PG sub-study and the main study or just in the main study. |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Threshold based on historical SVR rates |
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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 | 26 |
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 |
Canada |
European Union |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 1 |
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 | 1 |
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 |