Hepatitis C Virus
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.; Secondary Objective: ? The percentages of subjects with on-treatment virologic failure. ? The percentages of subjects with post-treatment relapse. ;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;Timepoint(s) of evaluation of this end point: 12 weeks following the last dose of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ; Timepoint(s) of evaluation of this end point: ? Treatment Day 1 to end of treatment ? End of treatment to 24 weeks post treatment. | — |
Countries
Australia, Canada, New Zealand, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
Abbvie Ltd.
Outcome results
None listed