A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 99
Updated:2/2/2017
Start Date:October 2015
End Date:January 2017

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A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1 Infection (ENDURANCE-1)

This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with
Genotype 1 hepatitis C virus infection without cirrhosis


Inclusion Criteria:

1. Male or female, at least 18 years of age at time of screening.

2. Screening laboratory result indicating HCV GT1 infection.

3. Chronic HCV infection.

4. Subject must be HCV treatment-naïve (i.e., patient has never received a single dose
of any approved or investigational regimen) or treatment-experienced (has failed
prior IFN or pegIFN with or without RBV, or SOF plus RBV with or without pegIFN
therapy).

5. Subjects must be non-cirrhotic.

Additional Inclusion Criteria for GT1 HCV/HIV-1 co-infected patients:

6. HIV-1 ART naïve with CD4 ≥ 500 cells/mm3 (or CD4+ % ≥ 29%) at Screening and plasma
HIV-1 RNA <1,000 copies/mL at Screening and at least once during the 12 months prior
to Screening.

Or On a stable, qualifying HIV-1 ART regimen for at least 8 weeks prior to screening, with
CD4 ≥ 200 cells/mm3 (or CD4+ % ≥14%) at Screening and plasma HIV-1 RNA < LLOQ at Screening
and at least once during the 12 months prior to Screening.

Exclusion Criteria:

1. History of severe, life-threatening or other significant sensitivity to any
excipients of the study drugs.

2. 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.

3. 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.

4. Positive test result at Screening for hepatitis B surface antigen (HBsAg).

5. HCV genotype performed during screening indicating co-infection with more than one
HCV genotype.

6. Chronic human immunodeficiency virus, type 2 (HIV-2) infection.
We found this trial at
13
sites
Bakersfield, California 93301
Principal Investigator: Site Reference ID/Investigator# 140512, MD
863
mi
from 98109
Bakersfield, CA
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Adelaide,
Principal Investigator: Site Reference ID/Investigator# 141896, MD
8336
mi
from 98109
Adelaide,
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Catonsville, Maryland 21228
Principal Investigator: Site Reference ID/Investigator# 140800, MD
2323
mi
from 98109
Catonsville, MD
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Chicago, Illinois
Principal Investigator: Site Reference ID/Investigator# 140517, MD
1733
mi
from 98109
Chicago, IL
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Egg Harbor Township, New Jersey 08234
Principal Investigator: Site Reference ID/Investigator# 140821, MD
2420
mi
from 98109
Egg Harbor Township, NJ
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Indianapolis, Indiana 46202
Principal Investigator: Site Reference ID/Investigator# 140709, MD
1867
mi
from 98109
Indianapolis, IN
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Jacksonville, Florida 32209
Principal Investigator: Site Reference ID/Investigator# 140510, MD
2449
mi
from 98109
Jacksonville, FL
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Madison, Wisconsin 53792
Principal Investigator: Site Reference ID/Investigator# 140715, MD
1616
mi
from 98109
Madison, WI
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Nashville, Tennessee 37232
Principal Investigator: Site Reference ID/Investigator# 140677, MD
1970
mi
from 98109
Nashville, TN
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Novi, Michigan 48377
Principal Investigator: Site Reference ID/Investigator# 140534, MD
1908
mi
from 98109
Novi, MI
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1065
mi
from 98109
San Diego, CA
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2
mi
from 98109
Seattle, WA
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Statesville, North Carolina 28677
Principal Investigator: Site Reference ID/Investigator# 140804, MD
2257
mi
from 98109
Statesville, NC
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