A Study to Evaluate Chronic Hepatitis C Infection



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:3/30/2013
Start Date:November 2012
End Date:June 2014
Contact:Melanie Gloria, BS
Email:melanie.gloria@abbvie.com
Phone:847-936-0714

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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I)


A study to evaluate chronic hepatitis C 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 co-administered with ribavirin in hepatitis C virus
genotype 1 infected treatment-naïve adults (SAPPHIRE-I).

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 1-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 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
31
sites
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Dothan, AL
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Aurora, CO
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Bakersfield, CA
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Birmingham, AL
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Charlotte, North Carolina 28207
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Charlotte, NC
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Chicago, IL
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Cincinnati, OH
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1965
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Detroit, MI
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Egg Harbor Township, New Jersey 08234
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Egg Harbor Township, NJ
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Fairfax, VA
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Fort Pierce, FL
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Gainesville, FL
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Houston, TX
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Jackson, MS
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Kansas City, MO
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Lutherville, MD
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Madison, WI
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New York, NY
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New York, NY
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Newport News, VA
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Philadelphia, Pennsylvania 19106
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Philadelphia, PA
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San Antonio, TX
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San Diego, CA
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San Diego, CA
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Seattle, WA
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Shreveport, LA
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St. Louis, MO
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Washington, District of Columbia 20009
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Washington,
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Wellington, FL
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Winston-Salem, North Carolina 27103
2123
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Winston-Salem, NC
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2145
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Zephyrhills, FL
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