A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:5/27/2013
Start Date:March 2013
End Date:November 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-Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) INfection (PEARL-IV)


This is a study to evaluate chronic hepatitis C infection in adults with genotype 1a
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 1a-infected treatment-naïve adults (PEARL-IV).

Inclusion Criteria:

- Males or females 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 1a-infection (HCV RNA level greater than or equal to
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 or alcohol

- Significant sensitivity to any drug

- Use of contraindicated medications within 2 weeks of dosing

- Abnormal laboratory tests

- Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus antibody
We found this trial at
21
sites
San Francisco, California 94115
1340
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San Francisco, CA
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from
Atlanta, GA
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1144
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Coronado, CA
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DeLand, FL
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Egg Harbor Township, New Jersey 08234
1257
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Egg Harbor Township, NJ
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1114
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from
Fairfax, VA
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481
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from
Germantown, TN
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1252
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from
Hillsborough, NJ
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569
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from
Houston, TX
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1303
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from
Manhasset, NY
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633
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from
Milwaukee, WI
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552
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from
Minneapolis, MN
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778
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from
Murray, UT
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Newport Beach, California 92663
1161
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from
Newport Beach, CA
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1424
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from
Providence, RI
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1122
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Riverside, CA
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San Diego, CA
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1139
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from
San Diego, CA
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San Francisco, California 94109
1339
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from
San Francisco, CA
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1284
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from
West Palm Beach, FL
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Wilmington, North Carolina 28403
1134
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from
Wilmington, NC
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