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



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:7/4/2018
Start Date:February 2012
End Date:June 2013

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An Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects

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.

An open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and
antiviral activity of ABT-267 as monotherapy for 2 days, followed by ABT-267, ABT-450 with
ritonavir (ABT-450/r) and ABT-333 plus ribavirin (RBV) combination therapy for 12 weeks in
treatment-naïve, non-cirrhotic patients with chronic hepatitis C virus (HCV) infection. The
study included post-treatment follow-up for 48 weeks.

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.
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