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