Overview

Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects

Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir) administered as two-day monotherapy followed by ABT-267 in combination therapy with other direct-acting antiviral agents (DAAs) ABT-450 with ritonavir (ABT-450/r) and ABT-333 (also known as dasabuvir) plus ribavirin (RBV) in patients with chronic Hepatitis C virus (HCV) infection without cirrhosis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Treatments:
Antiviral Agents
Ribavirin
Ritonavir
Criteria
Inclusion Criteria:

- Male or female between the age of 18 and 70 years, inclusive, at time of enrollment.

- Subject has never received antiviral treatment for hepatitis C virus (HCV) infection.

- Body mass index (BMI) is ≥ 18 to < 38 kg/m^2. BMI is calculated as weight measured in
kilograms (kg) divided by the square of height measured in meters (m).

- Chronic HCV genotype 1-infection for at least 6 months prior to study enrollment.

- Subject has plasma HCV RNA level > 10,000 IU/mL at screening

Exclusion Criteria:

- History of severe, life-threatening or other significant sensitivity to any drug.

- Females who are or plan to become pregnant or breastfeeding or males whose partner is
pregnant or planning to become pregnant.

- Recent history of drug or alcohol abuse that could preclude adherence to the protocol.

- Positive test result for hepatitis B surface antigen or anti-human immunodeficiency
virus (HIV) antibodies.

- Any current or past clinical evidence of cirrhosis (e.g., ascites, esophageal
varices), or a liver biopsy or FibroTest/aspartate aminotransferase to platelet ratio
(APRI) or FibroScan® showing cirrhosis or extensive bridging fibrosis.