Chronic HCV Genotype 3 Infection MedDRA version: 18.1 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: 1. Male or female, at least 18 years of age at time of Screening. 2. Screening laboratory result indicating HCV GT3 infection. 3. Chronic HCV infection. 4. Subject must be treatment-naïve. 5. Subjects must be non-cirrhotic. 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 415 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
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 demonstrate non-inferiority in the percentage of subjects achieving a 12-week sustained virologic response (SVR12) of 12 weeks of treatment with ABT-493/ABT-530 to 12 weeks of treatment with Sofosbuvir and Daclatasvir, to demonstrate non-inferiority of 8 weeks of Treatment with ABT-493/ABT-530, and to assess safety of ABT-493/ABT-530 compared to Sofosbuvir and Daclatasvir in treatment-naïve adults with chronic HCV GT3 infection.;Secondary Objective: To assess: ? The superiority of 12 weeks ABT-493/ABT-530 to SOF and DCV based on SVR12; ? 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 achieving SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug);Timepoint(s) of evaluation of this end point: Post-Treatment Week 12 visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Superiority in SVR12 rates of the test regimen to the control regimen 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), and ? 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).;Timepoint(s) of evaluation of this end point: Post-Treatment Week 12, End of Treatment, End of Study | — |
Countries
Australia, Canada, France, Germany, New Zealand, Russian Federation, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
Abbvie Ltd.
Outcome results
None listed