An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects with Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-I)
- Conditions
- Chronic Hepatitis C Virus (HCV) InfectionMedDRA version: 17.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-002925-36-GB
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 174
1.Male or female between 18 and 70 years of age, inclusive, at time of screening
2.Screening laboratory result indicating HCV GT1, GT4, GT5, or GT6 infection
3.Chronic HCV infection
4.Subject must be either HCV treatment-naïve or PR experienced (PR-null responder in Part 1).
5.Per local standards, subjects are considered to be non-cirrhotic or to have compensated cirrhosis (Part 2 GT1 only).
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 310
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1.History of severe, life-threatening or other significant sensitivity to any drug.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy and safety of ABT-493 and ABT-530 with and without ribavirin (RBV) in subjects with chronic HCV genotype (GT) 1, 4, 5, and 6 infection with compensated cirrhosis (GT1 only) or without cirrhosis (all genotypes);Secondary Objective: To assess the pharmacokinetics of ABT-493, ABT-530, and RBV and the emergence and persistence of viral variants with this treatment regimen;Primary end point(s): The percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug) in each treatment arm.;Timepoint(s) of evaluation of this end point: 12 weeks following last dose of study drug
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): ·The percentage of subjects with SVR4 (HCV RNA < LLOQ 4 weeks after the last actual dose of study drug);<br> ·The percentage of subjects with on-treatment virologic failure;<br> ·The percentage of subjects with post-treatment relapse.<br> ;Timepoint(s) of evaluation of this end point: 12 weeks following last subject last dose of study drug