Hepatitis C Infection MedDRA version: 19.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Arms A, B and C: -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 Arm D: -Subject must have prior treatment experience with SOF/pegIFN/RBV or SOF/RBV and meet one of the following categories: * Prior SOF breakthrough/non-responder: HCV RNA detectable at the end of treatment with SOF/pegIFN/RBV or SOF/RBV; * Prior SOF relapser: achieved HCV RNA undetectable at end of a prior treatment course SOF/pegIFN/RBV or SOF/RBV, but HCV RNA was detectable within 52 weeks following completion of therapy. 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 155 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 commercially available (including previous exposure to ABT-450 or ombitasvir), or receipt of any investigational product within 6 weeks prior to study drug administration. Prior use of any direct-acting antiviral will not be allowed, except for Arm D where prior experience with the nucleoside polymerase inhibitor, sofosbuvir with pegIFN/RBV or RBV, is required -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study in HCV genotype 4-infected subjects with compensated cirrhosis receiving treatment with co-formulated ombitasvir/ABT-450/ritonavir co-administered with RBV for 12, 16, or 24 weeks are to assess the safety and to compare the percentage of subjects, who are either treatment-naïve or who have previously received only IFN/RBV treatment for HCV, achieving a 12-week sustained virologic response, SVR12 (HCV ribonucleic acid [RNA] < lower limit of quantification [LLOQ] 12 weeks following treatment), to a clinically relevant threshold (based on SVR rates for HCV genotype 4-infected subjects treated with pegIFN/RBV).;Secondary Objective: The secondary objectives of this study are to assess the following in HCV genotype 4-infected subjects with compensated cirrhosis who are either treatment-naïve or who have previously received only IFN/RBV treatment for HCV: To compare the SVR12 following 12 weeks of treatment (Arm A) to the SVR12 following 16 weeks of treatment (Arm B), To compare the SVR12 following 16 weeks of treatment (Arm B) to the SVR12 following 24 weeks of treatment (Arm C), To assess the percentage of subjects with on-treatment virologic failure during 12, 16, or 24 weeks of treatment (each of Arms A, B and C), and To assess the percentage of subjects experiencing post-treatment relapse within 12 weeks following the end of either 12, 16, or 24 weeks of treatment (Relapse12) (each of Arms A, B and C).;Primary end point(s): The primary efficacy endpoint is the percentage of subjects with SVR12.;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drugs | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints are: a)The percentage of subjects with SVR12 in Arm B compared to Arm A; b)The percentage of subjects with SVR12 in Arm C compared to Arm B; c)The percentage of subjects in Arms A, B, and C with on-treatment virologic failure during the Treatment Period (defined as confirmed HCV RNA = LLOQ after HCV RNA < LLOQ during treatment or confirmed HCV RNA = LLOQ at the end of treatment); d)The percentage of subjects in Arms A, B, and C 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 completing treatment and with HCV RNA < LLOQ at the end of treatment).;Timepoint(s) of evaluation of this end point: a) 12 weeks after last dose of study drug; b) 12 weeks after last dose of study drug; c) up to 24 weeks after first dose of study drug d) within 12 weeks after the last dose of study drug | — |
Countries
Austria, Belgium, Canada, European Union, France, Germany, Greece, Italy, Spain, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed