Chronic Hepatitis C Infection
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, 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. 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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.;Primary end point(s): The primary efficacy endpoint is SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug).;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| 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).;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. | — |
Countries
Belgium, Canada, Germany, South Africa, Spain, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
Abbvie Ltd.
Outcome results
None listed