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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Trial Summary
Trial Overview
Inclusion Criteria

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
Clinical Trial Facility in Birmingham Alabama
Birmingham, Alabama
Principal Investigator: Site Reference ID/Investigator# 132641, MD
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Birmingham, AL
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Clinical Trial Facility in Adelaide
Adelaide,
Principal Investigator: Site Reference ID/Investigator# 130887, MD
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Adelaide,
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Clinical Trial Facility in Allentown Pennsylvania
Allentown, Pennsylvania
Principal Investigator: Site Reference ID/Investigator# 132608, MD
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Allentown, PA
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Clinical Trial Facility in Arlington Texas
Arlington, Texas 76017
Principal Investigator: Site Reference ID/Investigator# 130740, MD
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Arlington, TX
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Clinical Trial Facility in Asheville North Carolina
Asheville, North Carolina
Principal Investigator: Site Reference ID/Investigator# 132611, MD
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Asheville, NC
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Clinical Trial Facility in Atlanta Georgia
Atlanta, Georgia
Principal Investigator: Site Reference ID/Investigator# 132609, MD
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Atlanta, GA
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Clinical Trial Facility in Atlanta Georgia
Atlanta, Georgia
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Clinical Trial Facility in Atlanta Georgia
Atlanta, Georgia
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Atlanta, GA
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Clinical Trial Facility in Aurora Colorado
Aurora, Colorado 80045
Principal Investigator: Site Reference ID/Investigator# 130737, MD
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Aurora, CO
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Clinical Trial Facility in Bakersfield California
Bakersfield, California 93301
Principal Investigator: Site Reference ID/Investigator# 130738, MD
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Bakersfield, CA
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Clinical Trial Facility in Baltimore Maryland
Baltimore, Maryland
Principal Investigator: Site Reference ID/Investigator# 130750, MD
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Baltimore, MD
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Clinical Trial Facility in Baltimore Maryland
Baltimore, Maryland
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Baltimore, MD
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Clinical Trial Facility in Bastrop Louisiana
Bastrop, Louisiana 71220
Principal Investigator: Site Reference ID/Investigator# 132917, MD
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Bastrop, LA
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Clinical Trial Facility in Binghamton New York
Binghamton, New York 13901
Principal Investigator: Site Reference ID/Investigator# 130734, MD
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Binghamton, NY
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Clinical Trial Facility in Catonsville Maryland
Catonsville, Maryland 21228
Principal Investigator: Site Reference ID/Investigator# 132631, MD
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Catonsville, MD
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Clinical Trial Facility in Chevy Chase Maryland
Chevy Chase, Maryland 20815
Principal Investigator: Site Reference ID/Investigator# 135352, MD
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Chevy Chase, MD
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Clinical Trial Facility in Chicago Illinois
Chicago, Illinois
Principal Investigator: Site Reference ID/Investigator# 132606, MD
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Chicago, IL
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Clinical Trial Facility in Coronado California
Coronado, California 92118
Principal Investigator: Site Reference ID/Investigator# 132612, MD
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Coronado, CA
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Clinical Trial Facility in Dothan Alabama
Dothan, Alabama 36303
Principal Investigator: Site Reference ID/Investigator# 130743, MD
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Dothan, AL
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Clinical Trial Facility in Durham North Carolina
Durham, North Carolina
Principal Investigator: Site Reference ID/Investigator# 132622, MD
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Durham, NC
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Clinical Trial Facility in Falls Church Virginia
Falls Church, Virginia 22042
Principal Investigator: Site Reference ID/Investigator# 132603, MD
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Falls Church, VA
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Clinical Trial Facility in Germantown Tennessee
Germantown, Tennessee 38138
Principal Investigator: Site Reference ID/Investigator# 132649, MD
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Germantown, TN
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Clinical Trial Facility in Houston Texas
Houston, Texas
Principal Investigator: Site Reference ID/Investigator# 132648, MD
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Houston, TX
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Clinical Trial Facility in Houston Texas
Houston, Texas
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Houston, TX
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Clinical Trial Facility in Indianapolis Indiana
Indianapolis, Indiana 46202
Principal Investigator: Site Reference ID/Investigator# 130745, MD
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Indianapolis, IN
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Clinical Trial Facility in Kansas City Missouri
Kansas City, Missouri 64108
Principal Investigator: Site Reference ID/Investigator# 132607, MD
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Kansas City, MO
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Clinical Trial Facility in La Jolla California
La Jolla, California 92093
Principal Investigator: Site Reference ID/Investigator# 132629, MD
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La Jolla, CA
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Clinical Trial Facility in Lebanon New Hampshire
Lebanon, New Hampshire
Principal Investigator: Site Reference ID/Investigator# 132604, MD
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Lebanon, NH
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Clinical Trial Facility in Los Angeles California
Los Angeles, California
Principal Investigator: Site Reference ID/Investigator# 130742, MD
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Los Angeles, CA
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Clinical Trial Facility in Los Angeles California
Los Angeles, California
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Clinical Trial Facility in Miami Florida
Miami, Florida 33136
Principal Investigator: Site Reference ID/Investigator# 132627, MD
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Miami, FL
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Clinical Trial Facility in Nashville Tennessee
Nashville, Tennessee 37232
Principal Investigator: Site Reference ID/Investigator# 132613, MD
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Nashville, TN
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Clinical Trial Facility in New York New York
New York, New York 10032
Principal Investigator: Site Reference ID/Investigator# 132628, MD
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New York, NY
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Clinical Trial Facility in New York New York
New York, New York 10032
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New York, NY
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Clinical Trial Facility in Newark New Jersey
Newark, New Jersey
Principal Investigator: Site Reference ID/Investigator# 132638, MD
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Newark, NJ
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Clinical Trial Facility in Newport News Virginia
Newport News, Virginia 23601
Principal Investigator: Site Reference ID/Investigator# 132634, MD
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Newport News, VA
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Clinical Trial Facility in Novi Michigan
Novi, Michigan 48377
Principal Investigator: Site Reference ID/Investigator# 132610, MD
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Novi, MI
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Clinical Trial Facility in Orlando Florida
Orlando, Florida 32804
Principal Investigator: Site Reference ID/Investigator# 132614, MD
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Orlando, FL
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Clinical Trial Facility in Philadelphia Pennsylvania
Philadelphia, Pennsylvania
Principal Investigator: Site Reference ID/Investigator# 132625, MD
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Philadelphia, PA
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Clinical Trial Facility in Phoenix Arizona
Phoenix, Arizona
Principal Investigator: Site Reference ID/Investigator# 130755, MD
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Phoenix, AZ
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Clinical Trial Facility in Pittsburgh Pennsylvania
Pittsburgh, Pennsylvania
Principal Investigator: Site Reference ID/Investigator# 132630, MD
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Pittsburgh, PA
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Clinical Trial Facility in Portland Oregon
Portland, Oregon
Principal Investigator: Site Reference ID/Investigator# 130739, MD
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Portland, OR
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Clinical Trial Facility in Providence Rhode Island
Providence, Rhode Island
Principal Investigator: Site Reference ID/Investigator# 132642, MD
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Providence, RI
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Clinical Trial Facility in Providence Rhode Island
Providence, Rhode Island
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Providence, RI
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Clinical Trial Facility in Rochester New York
Rochester, New York
Principal Investigator: Site Reference ID/Investigator# 132620, MD
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Rochester, NY
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Clinical Trial Facility in Sacramento California
Sacramento, California 95825
Principal Investigator: Site Reference ID/Investigator# 132602, MD
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Sacramento, CA
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Clinical Trial Facility in San Antonio Texas
San Antonio, Texas 78224
Principal Investigator: Site Reference ID/Investigator# 131529, MD
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San Antonio, TX
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Clinical Trial Facility in San Diego California
San Diego, California
Principal Investigator: Site Reference ID/Investigator# 132601, MD
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San Diego, CA
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Clinical Trial Facility in San Diego California
San Diego, California
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Clinical Trial Facility in San Diego California
San Diego, California
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Clinical Trial Facility in San Diego California
San Diego, California
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Clinical Trial Facility in San Diego California
San Diego, California
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Clinical Trial Facility in San Diego California
San Diego, California
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Clinical Trial Facility in San Francisco California
San Francisco, California
Principal Investigator: Site Reference ID/Investigator# 132600, MD
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Clinical Trial Facility in San Francisco California
San Francisco, California
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Clinical Trial Facility in Seattle Washington
Seattle, Washington 98105
Principal Investigator: Site Reference ID/Investigator# 132637, MD
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Seattle, WA
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Clinical Trial Facility in Shreveport Louisiana
Shreveport, Louisiana 71103
Principal Investigator: Site Reference ID/Investigator# 130733, MD
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Shreveport, LA
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Clinical Trial Facility in St. Louis Missouri
St. Louis, Missouri 63104
Principal Investigator: Site Reference ID/Investigator# 132599, MD
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St. Louis, MO
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Clinical Trial Facility in St. Paul Minnesota
St. Paul, Minnesota 55114
Principal Investigator: Site Reference ID/Investigator# 132639, MD
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St. Paul, MN
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