Overview

Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected participants.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Treatments:
Interferons
Peginterferon alfa-2a
Ribavirin
Criteria
Inclusion Criteria:

- Treatment naïve participants

- Females must be either postmenopausal for at least 2 years or surgically sterile

- Males must be surgically sterile or practicing specific forms of birth control

- Chronic hepatitis C virus (HCV), genotype-1 infected participants

- Documented FibroTest score in combination with an Aspartate Aminotransferase to
Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document
absence of cirrhosis

Exclusion Criteria:

- Pregnant or breastfeeding female

- Use of any medications contraindicated for use with pegylated interferon(pegIFN) or
ribavirin (RBV) 2 weeks prior to study drug administration or 10 half-lives, whichever
is longer

- Clinically significant cardiac, respiratory (except mild asthma), renal,
gastrointestinal, hematologic, neurologic disease, or any uncontrolled medical illness
or psychiatric disease or disorder

- Current or past clinical evidence of cirrhosis or bridging fibrosis

- Abnormal screening laboratory results