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

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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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16
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Germantown, TN
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778
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697
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New Orleans, LA
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Philadelphia, Pennsylvania 19140
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Philadelphia, Pennsylvania 19104
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