E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
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 objectives of this study are to compare the 12-week sustained virologic response, SVR12 (HCV RNA < LLOQ 12 weeks following therapy) of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with HCV genotype 1 – 6 infection who are post primary orthotopic liver transplant or renal transplant to a pre-defined threshold, based on the historical SVR12 rates for the current standard of care regimens (sofosbuvir/ledipasvir plus ribavirin or sofosbuvir plus daclatasvir plus RBV) and to assess the safety of treatment with the ABT-493/ABT-530 combination regimen for 12 weeks in adults with HCV genotype GT1 – 6 infection and post primary orthotopic liver transplant or renal transplant. |
|
E.2.2 | Secondary objectives of the trial |
● The percentages of subjects with on-treatment virologic failure.
● The percentages of subjects with post-treatment relapse.
|
|
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 |
|
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 – 6 infection.
3. Subject is a recipient of a cadaveric or living donor liver transplant which was a consequence of HCV infection ≥ 3 months prior to screening Or Subject received a cadaveric or living donor kidney at least ≥ 3 months before screening.
4. Subjects must be documented as non-cirrhotic.
5. Subject is currently taking a stable immunosuppression regimen based on tacrolimus, sirolimus, everolimus, mycophenolate mofetil (MMF), mycophenolic acid, azathioprine, and/or cyclosporine. |
|
E.4 | Principal exclusion criteria |
1. Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
2. Clinical history of fibrosing cholestatic hepatitis post-transplant.
3. Re-transplantation of the liver or kidney.
4. Steroid resistant rejection of the transplanted liver or kidney, or a history of rejection treated with high dose steroid within 3 months of screening.
5. History of post-transplant complications related to hepatic or renal vasculature. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
● The percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug) for all intent-to-treat (ITT) subjects treated with ABT-493/ABT-530. Non-inferiority of the SVR12 rate for the ABT-493/ABT-530 regimen compared to the historical SVR12 rate for the current standard of care regimens (based on SVR12 rates for SOF/ledipasvir (LDV) plus RBV or SOF plus daclatasvir (DCV) plus RBV as reported in the SOLAR-1, SOLAR-2 and ALLY-1 studies) will be tested |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks following the last dose of study drug |
|
E.5.2 | Secondary end point(s) |
● The percentage of subjects with on-treatment virologic failure for subjects treated with ABT-493/ABT-530,
● The percentage of subjects with post-treatment relapse for subjects treated with ABT-493/ABT-530. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
● Treatment Day 1 to end of treatment
● End of treatment to 24 weeks post treatment. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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 |
New Zealand |
Taiwan |
United States |
|
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 | |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |