E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C Infection |
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E.1.1.1 | Medical condition in easily understood language |
Hepatitis C Virus Infection |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
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 of this study is to evaluate the effect of response to treatment by evaluating the percentage of subjects achieving a 12-week sustained virologic response (SVR12) following 12 weeks of treatment with ABT-493/ABT-530 and to evaluate safety of ABT-493/ABT-530 in adults with chronic HCV GT1, 2, 4, 5 or 6 infection and compensated cirrhosis |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess the percentages of subjects with on-treatment virologic failure and the percentages of subjects with post-treatment relapse. Additional objectives are to assess pharmacokinetics and the emergence and persistence of viral variants in this treatment regimen. |
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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 |
2 optional sub-studies. Both substudies are described in the M14-172 Protocol.
Specific purposes of the optional pharmacogenetic sub-study include:
● To find out why some patients with HCV respond better or worse to ABT-493 and ABT-530 or drugs of the same or similar class
● To possibly find out how HCV and related conditions develop and progress and how they can be diagnosed, monitored or treated
● To possibly develop tests that identify which patients are likely to have specific diseases, respond to ABT-493 and ABT-530 or drugs of the same or similar class, or to predict the progression of HCV
● To possibly develop new therapies, research methods or technologies.
Specific purposes of the optional pharmacokinetic sub-study include:
● To further understand how much study drug is in your body and how your body handles the study drugs. |
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E.3 | Principal inclusion criteria |
1. Male or female, at least 18 years of age at time of Screening.
2. Screening laboratory result indicating HCV GT1, 2, 4, 5, or 6 infection.
3. Chronic HCV infection.
4. Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or has failed prior IFN or pegIFN with or without RBV, or SOF plus RBV with or without pegIFN therapy. Prior HCV treatment with any other approved or investigational medications is not allowed.
5. Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease. |
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E.4 | Principal exclusion criteria |
1. History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
2. Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male
whose partner is pregnant or planning to become pregnant during the study.
3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that
could preclude adherence to the protocol in the opinion of the investigator.
4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human
immunodeficiency virus antibody (HIV Ab).
5. HCV genotype performed during screening indicating co-infection with more than one HCV
genotype.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after last dose of study drug |
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E.5.2 | Secondary end point(s) |
The secondary efficacy endpoints are:
● the percentage of subjects with on-treatment virologic failure (defined as confirmed increase of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment);
● the percentage of subjects with post-treatment relapse (defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among subjects who completed treatment as planned with HCV RNA < LLOQ at the end of treatment; with further breakdown by relapse versus reinfection based on HCV population sequencing). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Treatment Day 1 to end of treatment and end of treatment to 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 | No |
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 | 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 | 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.8.3 |
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 | 5 |
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 |
Belgium |
Canada |
Germany |
South Africa |
Spain |
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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last subject last visit (Post-Treatment Week 24). |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
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 | 0 |