A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 11/23/2013 |
Start Date: | August 2012 |
End Date: | February 2015 |
Contact: | Andrew Coates |
Email: | andrew.coates@abbvie.com |
Phone: | 847-938-1394 |
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Coadministration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection (PEARL-I)
The purpose of this study is to evaluate the safety and effect of co-administration of
ABT-450 with ritonavir (ABT-450/r) and ABT-267 in adults with chronic hepatitis C virus
infection.
Inclusion Criteria:
- Subjects must meet one of the following:
- Treatment-naive: Subject has never received antiviral treatment for hepatitis C
infection OR
- Treatment Experienced (Prior null responders, Partial responders or Relapsers to
pegIFN/RBV);
- Body mass index (BMI) is ≥ 18 to < 38 kg/m2.
- Chronic HCV genotype 1b infection/with or without cirrhosis or HCV genotype 4
infection/without cirrhosis for at least 6 months prior to study screening.
- 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 pregnant or breastfeeding.
- 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.
We found this trial at
15
sites
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