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 |
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.
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
Gainesville, Florida 32610
Principal Investigator: Site Reference ID/Investigator# 143508, MD
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Albuquerque, New Mexico
Principal Investigator: Site Reference ID/Investigator# 143463, MD
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Antwerp, 2180
Principal Investigator: Site Reference ID/Investigator# 143290, MD
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Arlington, Texas 76017
Principal Investigator: Site Reference ID/Investigator# 149796, MD
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Bakersfield, California 93301
Principal Investigator: Site Reference ID/Investigator# 149795, MD
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Chapel Hill, North Carolina
Principal Investigator: Site Reference ID/Investigator# 144121, MD
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Charlotte, North Carolina 28207
Principal Investigator: Site Reference ID/Investigator# 143409, MD
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Fort Pierce, Florida 34982
Principal Investigator: Site Reference ID/Investigator# 144858, MD
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Manhasset, New York 11031
Principal Investigator: Site Reference ID/Investigator# 143478, MD
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Portland, Oregon
Principal Investigator: Site Reference ID/Investigator# 143381, MD
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Providence, Rhode Island
Principal Investigator: Site Reference ID/Investigator# 143356, MD
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San Diego, California
Principal Investigator: Site Reference ID/Investigator# 143509, MD
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San Jose, California 95117
Principal Investigator: Site Reference ID/Investigator# 144079, MD
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Seattle, Washington 98105
Principal Investigator: Site Reference ID/Investigator# 143360, MD
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Shreveport, Louisiana 71103
Principal Investigator: Site Reference ID/Investigator# 148923, MD
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