A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection



Status:Active, not recruiting
Conditions:Infectious Disease, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 100
Updated:7/28/2016
Start Date:September 2014
End Date:January 2017

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A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection (SURVEYOR-II)

The purpose of this study is to evaluate the safety and efficacy of ABT-493 and ABT-530 (or
ABT-493/ABT-530) coadministered with and without ribavirin in adults with chronic HCV
genotypes 2, 3, 4, 5 or 6 infection.

In part 4, the primary objectives also include to assess the efficacy (SVR12) of treatment
with ABT-493/ABT-530 combination regimen in GT2-infected DAA-naive subjects without
cirrhosis compared to historical SVR12 rate of treatment with sofosbuvir plus RBV in
GT2-infected DAA-naive subjects without cirrhosis.


Inclusion Criteria:

- Male or female between at least 18 years of age at time of Screening

- Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.

- Chronic HCV infection.

- Subject must be either HCV treatment-naïve or treatment-experienced.

- Subject must be documented as non-cirrhotic or as having compensated cirrhosis (GT3
only).

Exclusion Criteria:

- History of severe, life-threatening or other significant sensitivity to any drug.

- 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
59
sites
Baltimore, Maryland
Principal Investigator: Site Reference ID/Investigator# 130750, MD
344
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from 43215
Baltimore, MD
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Adelaide,
Principal Investigator: Site Reference ID/Investigator# 130887, MD
10147
mi
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Adelaide,
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Allentown, Pennsylvania
Principal Investigator: Site Reference ID/Investigator# 132608, MD
400
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from 43215
Allentown, PA
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Arlington, Texas 76017
Principal Investigator: Site Reference ID/Investigator# 130740, MD
933
mi
from 43215
Arlington, TX
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Asheville, North Carolina
Principal Investigator: Site Reference ID/Investigator# 132611, MD
302
mi
from 43215
Asheville, NC
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Atlanta, Georgia
Principal Investigator: Site Reference ID/Investigator# 132609, MD
436
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from 43215
Atlanta, GA
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436
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Atlanta, GA
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436
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Aurora, Colorado 80045
Principal Investigator: Site Reference ID/Investigator# 130737, MD
1154
mi
from 43215
Aurora, CO
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Bakersfield, California 93301
Principal Investigator: Site Reference ID/Investigator# 130738, MD
1980
mi
from 43215
Bakersfield, CA
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344
mi
from 43215
Baltimore, MD
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Bastrop, Louisiana 71220
Principal Investigator: Site Reference ID/Investigator# 132917, MD
699
mi
from 43215
Bastrop, LA
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Binghamton, New York 13901
Principal Investigator: Site Reference ID/Investigator# 130734, MD
398
mi
from 43215
Binghamton, NY
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Birmingham, Alabama
Principal Investigator: Site Reference ID/Investigator# 132641, MD
492
mi
from 43215
Birmingham, AL
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Catonsville, Maryland 21228
Principal Investigator: Site Reference ID/Investigator# 132631, MD
337
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Catonsville, MD
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Chevy Chase, Maryland 20815
Principal Investigator: Site Reference ID/Investigator# 135352, MD
323
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Chevy Chase, MD
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Chicago, Illinois
Principal Investigator: Site Reference ID/Investigator# 132606, MD
274
mi
from 43215
Chicago, IL
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Coronado, California 92118
Principal Investigator: Site Reference ID/Investigator# 132612, MD
1953
mi
from 43215
Coronado, CA
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Dothan, Alabama 36303
Principal Investigator: Site Reference ID/Investigator# 130743, MD
618
mi
from 43215
Dothan, AL
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Durham, North Carolina
Principal Investigator: Site Reference ID/Investigator# 132622, MD
354
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from 43215
Durham, NC
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Falls Church, Virginia 22042
Principal Investigator: Site Reference ID/Investigator# 132603, MD
320
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Falls Church, VA
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Germantown, Tennessee 38138
Principal Investigator: Site Reference ID/Investigator# 132649, MD
501
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Germantown, TN
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Houston, Texas
Principal Investigator: Site Reference ID/Investigator# 132648, MD
991
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Houston, TX
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991
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Houston, TX
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Indianapolis, Indiana 46202
Principal Investigator: Site Reference ID/Investigator# 130745, MD
166
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from 43215
Indianapolis, IN
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Kansas City, Missouri 64108
Principal Investigator: Site Reference ID/Investigator# 132607, MD
618
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Kansas City, MO
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La Jolla, California 92093
Principal Investigator: Site Reference ID/Investigator# 132629, MD
1926
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from 43215
La Jolla, CA
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Lebanon, New Hampshire
Principal Investigator: Site Reference ID/Investigator# 132604, MD
609
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from 43215
Lebanon, NH
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Los Angeles, California
Principal Investigator: Site Reference ID/Investigator# 130742, MD
1972
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Los Angeles, CA
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1972
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Los Angeles, CA
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Miami, Florida 33136
Principal Investigator: Site Reference ID/Investigator# 132627, MD
993
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Miami, FL
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Nashville, Tennessee 37232
Principal Investigator: Site Reference ID/Investigator# 132613, MD
331
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Nashville, TN
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New York, New York 10032
Principal Investigator: Site Reference ID/Investigator# 132628, MD
481
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New York, NY
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481
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New York, NY
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Newark, New Jersey
Principal Investigator: Site Reference ID/Investigator# 132638, MD
468
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Newark, NJ
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Newport News, Virginia 23601
Principal Investigator: Site Reference ID/Investigator# 132634, MD
407
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Newport News, VA
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Novi, Michigan 48377
Principal Investigator: Site Reference ID/Investigator# 132610, MD
177
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Novi, MI
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Orlando, Florida 32804
Principal Investigator: Site Reference ID/Investigator# 132614, MD
792
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Orlando, FL
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Philadelphia, Pennsylvania
Principal Investigator: Site Reference ID/Investigator# 132625, MD
416
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Philadelphia, PA
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Phoenix, Arizona
Principal Investigator: Site Reference ID/Investigator# 130755, MD
1662
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Pittsburgh, Pennsylvania
Principal Investigator: Site Reference ID/Investigator# 132630, MD
162
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Pittsburgh, PA
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Portland, Oregon
Principal Investigator: Site Reference ID/Investigator# 130739, MD
2026
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Portland, OR
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Providence, Rhode Island
Principal Investigator: Site Reference ID/Investigator# 132642, MD
619
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Providence, RI
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619
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Providence, RI
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Rochester, New York
Principal Investigator: Site Reference ID/Investigator# 132620, MD
355
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Rochester, NY
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Sacramento, California 95825
Principal Investigator: Site Reference ID/Investigator# 132602, MD
2039
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Sacramento, CA
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San Antonio, Texas 78224
Principal Investigator: Site Reference ID/Investigator# 131529, MD
1144
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San Antonio, TX
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San Diego, California
Principal Investigator: Site Reference ID/Investigator# 132601, MD
1951
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San Diego, CA
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1951
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1951
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1951
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1951
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San Francisco, California
Principal Investigator: Site Reference ID/Investigator# 132600, MD
2107
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Seattle, Washington 98105
Principal Investigator: Site Reference ID/Investigator# 132637, MD
2005
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Seattle, WA
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Shreveport, Louisiana 71103
Principal Investigator: Site Reference ID/Investigator# 130733, MD
789
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St. Louis, Missouri 63104
Principal Investigator: Site Reference ID/Investigator# 132599, MD
395
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St. Louis, MO
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St. Paul, Minnesota 55114
Principal Investigator: Site Reference ID/Investigator# 132639, MD
622
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St. Paul, MN
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