Chronic Hepatitis C Virus Genotype 4, 5 or 6 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 GT4, 5, or 6 infection. 3. Chronic HCV infection. 4. Subject must be HCV treatment-naïve (i.e., has never received a single dose of any approved or investigational regimen for treatment of HCV) 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. Previous HCV treatment must have been completed = 2 months prior to screening. 5. Subjects are considered to be non-cirrhotic as per protocol. 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. 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. 2. 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. 3. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). 4. HCV genotype performed during screening indicating co-infection with more than one HCV genotype. 5. History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.The percentage of subjects with on-treatment virologic failure 2. The percentage of subjects with post-treatment relapse ;Timepoint(s) of evaluation of this end point: 1. During treatment and at the end of treatment with at least 6 weeks of treatment. 2. At the 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). | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy (SVR12) and safety of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype (GT) 4, 5, or 6 infection without cirrhosis.;Secondary Objective: The percentages of subjects with on-treatment virologic failure. The percentage of subjects with post-treatment relapse.;Primary end point(s): 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 the last actual dose of study drug. | — |
Countries
Belgium, Canada, France, Italy, Portugal, South Africa, Spain, United Kingdom
Contacts
Public ContactEU Clinical Trials Helpdesk
Abbvie Ltd.
Outcome results
None listed