Status:
COMPLETED
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection
Lead Sponsor:
AbbVie
Conditions:
Chronic Hepatitis C
Hepatitis C Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) in chronic...
Detailed Description
The study consisted of four independent parts with treatment and post-treatment periods of enrollment. Parts 1 and 2 were the supportive/ exploratory parts (phase 2) of the study and part 3 and 4 were...
Eligibility Criteria
Inclusion
- Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.
- Chronic HCV infection.
- Participant had to be either HCV treatment-naïve or treatment-experienced.
- Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).
Exclusion
- History of severe, life-threatening or other significant sensitivity to any drug.
- Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
- 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.
- Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
- HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
Key Trial Info
Start Date :
September 19 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2017
Estimated Enrollment :
694 Patients enrolled
Trial Details
Trial ID
NCT02243293
Start Date
September 19 2014
End Date
February 23 2017
Last Update
July 30 2021
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