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
We found this trial at
16
sites
Philadelphia, Pennsylvania 19104
414
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from 43215
Philadelphia, PA
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436
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Atlanta, GA
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590
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Burlington, VT
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913
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Dallas, TX
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501
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Germantown, TN
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1978
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Los Angeles, CA
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494
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Manhasset, NY
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1514
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Murray, UT
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797
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New Orleans, LA
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809
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New Port Richey, FL
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800
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from 43215
Orlando, FL
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Philadelphia, Pennsylvania 19140
416
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from 43215
Philadelphia, PA
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344
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Richmond, VA
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1941
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San Diego, CA
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1939
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San Marcos, CA
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826
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Tampa, FL
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