A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis



Status:Recruiting
Conditions:Infectious Disease, Infectious Disease, Gastrointestinal, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:December 2015
End Date:January 2017
Contact:Leticia Canizaro
Email:leticia.canizaro@abbvie.com
Phone:985-727-9351

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A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (EXPEDITION-1)

The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following
12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5
or 6 infection and compensated cirrhosis.


Inclusion Criteria:

- Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or
6 infection

- Chronic HCV infection

- Subject must be HCV treatment-naïve or have failed prior HCV treatment

- Subject must have documented compensated cirrhosis and no current or past clinical
evidence of decompensated liver disease

Exclusion Criteria:

- Positive test result at screening for Hepatitis B surface antigen or anti-human
immunodeficiency virus antibody

- HCV genotype performed during screening indicating co-infection with more than 1 HCV
genotype

- Consideration by the investigator, for any reason, that the subject is an unsuitable
candidate to receive ABT-493/ABT-530
We found this trial at
15
sites
San Jose, California 95117
Principal Investigator: Site Reference ID/Investigator# 144079, MD
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San Jose, CA
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Albuquerque, New Mexico
Principal Investigator: Site Reference ID/Investigator# 143463, MD
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Albuquerque, NM
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Antwerp, 2180
Principal Investigator: Site Reference ID/Investigator# 143290, MD
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Antwerp,
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Arlington, Texas 76017
Principal Investigator: Site Reference ID/Investigator# 149796, MD
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Arlington, TX
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Bakersfield, California 93301
Principal Investigator: Site Reference ID/Investigator# 149795, MD
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Bakersfield, CA
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Chapel Hill, North Carolina
Principal Investigator: Site Reference ID/Investigator# 144121, MD
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Chapel Hill, NC
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Charlotte, North Carolina 28207
Principal Investigator: Site Reference ID/Investigator# 143409, MD
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Charlotte, NC
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Fort Pierce, Florida 34982
Principal Investigator: Site Reference ID/Investigator# 144858, MD
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Fort Pierce, FL
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Gainesville, Florida 32610
Principal Investigator: Site Reference ID/Investigator# 143508, MD
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Gainesville, FL
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Manhasset, New York 11031
Principal Investigator: Site Reference ID/Investigator# 143478, MD
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Manhasset, NY
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Portland, Oregon
Principal Investigator: Site Reference ID/Investigator# 143381, MD
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Portland, OR
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Providence, Rhode Island
Principal Investigator: Site Reference ID/Investigator# 143356, MD
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Providence, RI
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San Diego, California
Principal Investigator: Site Reference ID/Investigator# 143509, MD
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San Diego, CA
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Seattle, Washington 98105
Principal Investigator: Site Reference ID/Investigator# 143360, MD
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Seattle, WA
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Shreveport, Louisiana 71103
Principal Investigator: Site Reference ID/Investigator# 148923, MD
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Shreveport, LA
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