A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 2/10/2017 |
| Start Date: | December 2015 |
| End Date: | February 2017 |
A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered With Daclatasvir in Adults With Chronic Hepatitis C Virus Genotype 3 Infection (ENDURANCE-3)
The purpose of this study is to compare the safety and efficacy of ABT-493/ABT-530 to the
combination of Sofosbuvir (SOF) and Daclatasvir (DCV) in adults with genotype 3 chronic
hepatitis C virus (HCV) infection.
combination of Sofosbuvir (SOF) and Daclatasvir (DCV) in adults with genotype 3 chronic
hepatitis C virus (HCV) infection.
Inclusion Criteria:
- Screening laboratory result indicating HCV GT3 infection
- Chronic HCV infection
- Subject must be treatment-naïve
- Subjects must be non-cirrhotic
Exclusion Criteria:
- History of severe, life-threatening or other significant sensitivity to any
excipients of the study drugs.
- Female who is pregnant, planning to become pregnant during the study, or
breastfeeding; or male whose partner is pregnant or planning to become pregnant
during the study.
- Recent (within 6 months prior to study drug administration) history of drug or
alcohol abuse that could preclude adherence to the protocol in the opinion of the
investigator.
- Positive test result at Screening for hepatitis B surface antigen (HBsAg) or
anti-human immunodeficiency virus antibody (HIV Ab).
- HCV genotype performed during screening indicating co-infection with more than one
HCV genotype.
We found this trial at
30
sites
Santa Fe, New Mexico 87505
Principal Investigator: Site Reference ID/Investigator# 149153, MD, MPH
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Adelaide,
Principal Investigator: Site Reference ID/Investigator# 140296, MD
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Asheville, North Carolina
Principal Investigator: Site Reference ID/Investigator# 140083, MD
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Bakersfield, California 93301
Principal Investigator: Site Reference ID/Investigator# 140001, MD
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Birmingham, Alabama
Principal Investigator: Site Reference ID/Investigator# 140145, MD
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Bronx, New York
Principal Investigator: Site Reference ID/Investigator# 140137, MD
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Charlotte, North Carolina 28207
Principal Investigator: Site Reference ID/Investigator# 140081, MD
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Englewood, Colorado 80113
Principal Investigator: Site Reference ID/Investigator# 149154, MD
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Fort Pierce, Florida 34982
Principal Investigator: Site Reference ID/Investigator# 140051, MD
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Houston, Texas
Principal Investigator: Site Reference ID/Investigator# 140240, MD
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Lakewood, Colorado 80228
Principal Investigator: Site Reference ID/Investigator# 140029, MD
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Los Angeles, California
Principal Investigator: Site Reference ID/Investigator# 139996, MD
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Nashville, Tennessee 37232
Principal Investigator: Site Reference ID/Investigator# 140086, MD
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New Orleans, Louisiana
Principal Investigator: Site Reference ID/Investigator# 140243, MD
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Orlando, Florida 32804
Principal Investigator: Site Reference ID/Investigator# 140233, MD
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Phoenix, Arizona
Principal Investigator: Site Reference ID/Investigator# 140167, MD
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Portland, Oregon
Principal Investigator: Site Reference ID/Investigator# 146070, MD
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Poughkeepsie, New York 12601
Principal Investigator: Site Reference ID/Investigator# 140182, MD
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Providence, Rhode Island
Principal Investigator: Site Reference ID/Investigator# 140159, MD
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San Antonio, Texas 78224
Principal Investigator: Site Reference ID/Investigator# 140042, MD
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San Diego, California
Principal Investigator: Site Reference ID/Investigator# 140249, MD
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St. Paul, Minnesota 55114
Principal Investigator: Site Reference ID/Investigator# 140196, MD
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Statesville, North Carolina 28677
Principal Investigator: Site Reference ID/Investigator# 140062, MD
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West Palm Beach, Florida 33401
Principal Investigator: Site Reference ID/Investigator# 140010, MD
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