Overview

A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection

Status:
Completed
Trial end date:
2017-02-09
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this phase 3, multicenter study is to evaluate the efficacy and safety of ABT-493/ABT-530 in Japanese adults with chronic Hepatitis C Virus (HCV)-infected, HCV direct-acting antiviral agent (DAA) treatment-naïve, and DAA treatment-experienced Japanese adult subjects.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie
Treatments:
Ritonavir
Criteria
Inclusion Criteria:

- Females were postmenopausal for at least 2 years; surgically sterile or had a
vasectomized partner; or, if of childbearing potential and sexually active with a male
partner, were currently using at least 1 effective method of birth control at the time
of Screening and agreed to practice 1 effective method of birth control from Screening
through 30 days after stopping study drug. Sexually active males were surgically
sterile or, if sexually active with a female partner of childbearing potential, agreed
to practice 1 effective form of birth control from Screening through 30 days after
stopping study drug.

- Screening central laboratory result indicated HCV single genotype infection for the
appropriate treatment arm, without co-infection of any other genotype.

- Chronic HCV infection is defined as one of the following:

- Positive for anti-HCV antibody (Ab) and/or HCV RNA at least 6 months before
Screening.

- A liver biopsy consistent with chronic HCV infection.

- Agreed to voluntarily sign and date an informed consent form, approved by an
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) prior to the
initiation of any screening or study specific procedures.

- Participants who were able to understand and adhere to the study visit schedule and
all other protocol requirements.

- Absence of hepatocellular carcinoma (HCC) as indicated by an ultrasound, computed
tomography (CT) scan or magnetic resonance imaging (MRI).

Exclusion Criteria:

- Females who were pregnant or planned to become pregnant, or breastfeeding or males
whose partner was pregnant or planning to become pregnant during the study.

- Participants co-infected with hepatitis B virus or human immunodeficiency virus.

- Use of contraindicated medications or supplements within 2 weeks or 10 half-lives (if
known), whichever was longer, prior to the first dose of any study drug.

- 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.

- Any cause of liver disease other than chronic HCV infection.

- Any current or past clinical evidence of Child-Pugh B or C classification or clinical
history of decompensated liver disease.

- Consideration by the investigator, for any reason, that the participant is an
unsuitable candidate to receive ABT-493/ABT-530.