A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection
Status: | Completed |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 7/16/2013 |
Start Date: | February 2012 |
End Date: | August 2014 |
Contact: | Melanie Gloria, BS |
Email: | melanie.gloria@abbvie.com |
Phone: | (847) 936-0714 |
A Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naive Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL-III)
A study to evaluate chronic hepatitis C infection in adults with genotype 1b infection.
The purpose of this study is to evaluate the safety and effect of ABT-450, ritonavir and
ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin in hepatitis C virus
genotype 1b-infected treatment-naive adults (PEARL-III).
Inclusion Criteria:
- Males or female between 18 and 70 years old, inclusive
- Females must be post-menopausal for more than 2 years or surgically sterile or
practicing specific forms of birth control
- Chronic hepatitis C, genotype 1b infection (HCV RNA level greater than 10,000 IU/mL
at screening)
- Subject has never received antiviral treatment for hepatitis C infection
- No evidence of liver cirrhosis
Exclusion Criteria:
- Positive screen for drugs
- Significant sensitivity to any drug
- Use of contraindicated medications within 2 weeks of dosing
- Infection with any other genotype or subtype of hepatitis C
- Abnormal laboratory tests
- Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody
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