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

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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.


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
West Palm Beach, Florida 33401
Principal Investigator: Site Reference ID/Investigator# 140010, MD
2304
mi
from 91732
West Palm Beach, FL
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Adelaide,
Principal Investigator: Site Reference ID/Investigator# 140296, MD
8190
mi
from 91732
Adelaide,
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Asheville, North Carolina
Principal Investigator: Site Reference ID/Investigator# 140083, MD
2002
mi
from 91732
Asheville, NC
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Bakersfield, California 93301
Principal Investigator: Site Reference ID/Investigator# 140001, MD
106
mi
from 91732
Bakersfield, CA
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Birmingham, Alabama
Principal Investigator: Site Reference ID/Investigator# 140145, MD
1784
mi
from 91732
Birmingham, AL
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Bronx, New York
Principal Investigator: Site Reference ID/Investigator# 140137, MD
2436
mi
from 91732
Bronx, NY
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Charlotte, North Carolina 28207
Principal Investigator: Site Reference ID/Investigator# 140081, MD
2102
mi
from 91732
Charlotte, NC
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Englewood, Colorado 80113
Principal Investigator: Site Reference ID/Investigator# 149154, MD
815
mi
from 91732
Englewood, CO
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Fort Pierce, Florida 34982
Principal Investigator: Site Reference ID/Investigator# 140051, MD
2270
mi
from 91732
Fort Pierce, FL
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Houston, Texas
Principal Investigator: Site Reference ID/Investigator# 140240, MD
1357
mi
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Houston, TX
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1357
mi
from 91732
Houston, TX
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Lakewood, Colorado 80228
Principal Investigator: Site Reference ID/Investigator# 140029, MD
812
mi
from 91732
Lakewood, CO
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Los Angeles, California
Principal Investigator: Site Reference ID/Investigator# 139996, MD
13
mi
from 91732
Los Angeles, CA
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13
mi
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Los Angeles, CA
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Nashville, Tennessee 37232
Principal Investigator: Site Reference ID/Investigator# 140086, MD
1763
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from 91732
Nashville, TN
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New Orleans, Louisiana
Principal Investigator: Site Reference ID/Investigator# 140243, MD
1655
mi
from 91732
New Orleans, LA
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Orlando, Florida 32804
Principal Investigator: Site Reference ID/Investigator# 140233, MD
2182
mi
from 91732
Orlando, FL
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Phoenix, Arizona
Principal Investigator: Site Reference ID/Investigator# 140167, MD
343
mi
from 91732
Phoenix, AZ
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Portland, Oregon
Principal Investigator: Site Reference ID/Investigator# 146070, MD
827
mi
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Portland, OR
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827
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Portland, OR
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Poughkeepsie, New York 12601
Principal Investigator: Site Reference ID/Investigator# 140182, MD
2433
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Poughkeepsie, NY
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Providence, Rhode Island
Principal Investigator: Site Reference ID/Investigator# 140159, MD
2562
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Providence, RI
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2562
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Providence, RI
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San Antonio, Texas 78224
Principal Investigator: Site Reference ID/Investigator# 140042, MD
1188
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San Antonio, TX
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San Diego, California
Principal Investigator: Site Reference ID/Investigator# 140249, MD
105
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San Diego, CA
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105
mi
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San Diego, CA
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Santa Fe, New Mexico 87505
Principal Investigator: Site Reference ID/Investigator# 149153, MD, MPH
690
mi
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Santa Fe, NM
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964
mi
from 91732
Seattle, WA
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St. Paul, Minnesota 55114
Principal Investigator: Site Reference ID/Investigator# 140196, MD
1512
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St. Paul, MN
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Statesville, North Carolina 28677
Principal Investigator: Site Reference ID/Investigator# 140062, MD
2093
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Statesville, NC
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