Overview

A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus Infection

Status:
Completed
Trial end date:
2017-03-24
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this phase 3 study is to evaluate the efficacy and safety of ABT-493/ABT-530 in comparison to sofosbuvir plus ribavirin for 12 weeks in Hepatitis C Virus (HCV) Genotype 2 (GT2) infected participants.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie
Treatments:
Ribavirin
Sofosbuvir
Criteria
Inclusion Criteria:

- Females were postmenopausal for at least 2 years prior to screening; 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 indicating HCV GT-2 infection without co-infection
of any other genotype.

- Participant has positive anti-HCV antibody (Ab) and plasma HCV RNA viral load greater
than or equal to 1000 IU/mL at Screening Visit.

- Chronic HCV infection defined as one of the following:

- Positive for anti-HCV Ab and/or HCV RNA at least 6 months before Screening; or

- A liver biopsy consistent with chronic HCV infection.

- Participant must be HCV treatment-naïve (i.e., patient has not received a single dose
of any approved or investigational DAA) and non-cirrhotic. Prior HCV treatment using
IFNs with or without ribavirin is acceptable. Previous HCV Interferon (IFN) based
treatment must have been completed greater than or equal to 2 months prior to
screening.

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.

- 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).

- Requirement for and inability to safely discontinue contraindicated medications or
supplements at least 2 weeks or 10 half-lives (whichever is longer) prior to the first
dose of any study drug.

- Clinically significant abnormalities, other than HCV-infection, based upon the results
of a medical history, physical examination, vital signs, laboratory profile, and a
12-lead electrocardiogram (ECG) that make the participant an unsuitable candidate for
this study in the opinion of the investigator, including, but not limited to:

- Uncontrolled diabetes as defined by a glycated hemoglobin (hemoglobin A1C) level
> 8.5% at the Screening Visit.

- Active or suspected malignancy or history of malignancy (other than basal cell
skin cancer or cervical carcinoma in situ) in the past 5 years, or any history of
hepatocellular carcinoma (HCC).

- Uncontrolled cardiac, respiratory, gastrointestinal, hematologic, neurologic,
psychiatric, or other medical disease or disorder, which is unrelated to the
existing HCV infection.

- Any cause of liver disease other than chronic HCV-infection, including but not limited
to the following:

- Hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's disease, autoimmune
hepatitis, alcoholic liver disease, or steatohepatitis considered to be the
primary cause of the liver disease rather than concomitant/incidental with HCV
infection.