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

Use our guide to learn which trials are right for you!

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
Falls Church, Virginia 22042
Principal Investigator: Site Reference ID/Investigator# 132603, MD
1118
mi
from
Falls Church, VA
Click here to add this to my saved trials
Adelaide,
Principal Investigator: Site Reference ID/Investigator# 130887, MD
9338
mi
from
Adelaide,
Click here to add this to my saved trials
Allentown, Pennsylvania
Principal Investigator: Site Reference ID/Investigator# 132608, MD
1209
mi
from
Allentown, PA
Click here to add this to my saved trials
Arlington, Texas 76017
Principal Investigator: Site Reference ID/Investigator# 130740, MD
353
mi
from
Arlington, TX
Click here to add this to my saved trials
Asheville, North Carolina
Principal Investigator: Site Reference ID/Investigator# 132611, MD
858
mi
from
Asheville, NC
Click here to add this to my saved trials
Atlanta, Georgia
Principal Investigator: Site Reference ID/Investigator# 132609, MD
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
Aurora, Colorado 80045
Principal Investigator: Site Reference ID/Investigator# 130737, MD
402
mi
from
Aurora, CO
Click here to add this to my saved trials
Bakersfield, California 93301
Principal Investigator: Site Reference ID/Investigator# 130738, MD
1184
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Baltimore, Maryland
Principal Investigator: Site Reference ID/Investigator# 130750, MD
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bastrop, Louisiana 71220
Principal Investigator: Site Reference ID/Investigator# 132917, MD
481
mi
from
Bastrop, LA
Click here to add this to my saved trials
Binghamton, New York 13901
Principal Investigator: Site Reference ID/Investigator# 130734, MD
1195
mi
from
Binghamton, NY
Click here to add this to my saved trials
Birmingham, Alabama
Principal Investigator: Site Reference ID/Investigator# 132641, MD
683
mi
from
Birmingham, AL
Click here to add this to my saved trials
Catonsville, Maryland 21228
Principal Investigator: Site Reference ID/Investigator# 132631, MD
1141
mi
from
Catonsville, MD
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
Principal Investigator: Site Reference ID/Investigator# 135352, MD
1123
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
Chicago, Illinois
Principal Investigator: Site Reference ID/Investigator# 132606, MD
610
mi
from
Chicago, IL
Click here to add this to my saved trials
Coronado, California 92118
Principal Investigator: Site Reference ID/Investigator# 132612, MD
1144
mi
from
Coronado, CA
Click here to add this to my saved trials
Dothan, Alabama 36303
Principal Investigator: Site Reference ID/Investigator# 130743, MD
838
mi
from
Dothan, AL
Click here to add this to my saved trials
Durham, North Carolina
Principal Investigator: Site Reference ID/Investigator# 132622, MD
1051
mi
from
Durham, NC
Click here to add this to my saved trials
Germantown, Tennessee 38138
Principal Investigator: Site Reference ID/Investigator# 132649, MD
481
mi
from
Germantown, TN
Click here to add this to my saved trials
Houston, Texas
Principal Investigator: Site Reference ID/Investigator# 132648, MD
569
mi
from
Houston, TX
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Principal Investigator: Site Reference ID/Investigator# 130745, MD
643
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Kansas City, Missouri 64108
Principal Investigator: Site Reference ID/Investigator# 132607, MD
198
mi
from
Kansas City, MO
Click here to add this to my saved trials
La Jolla, California 92093
Principal Investigator: Site Reference ID/Investigator# 132629, MD
1118
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lebanon, New Hampshire
Principal Investigator: Site Reference ID/Investigator# 132604, MD
1393
mi
from
Lebanon, NH
Click here to add this to my saved trials
Los Angeles, California
Principal Investigator: Site Reference ID/Investigator# 130742, MD
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Miami, Florida 33136
Principal Investigator: Site Reference ID/Investigator# 132627, MD
1320
mi
from
Miami, FL
Click here to add this to my saved trials
Nashville, Tennessee 37232
Principal Investigator: Site Reference ID/Investigator# 132613, MD
618
mi
from
Nashville, TN
Click here to add this to my saved trials
New York, New York 10032
Principal Investigator: Site Reference ID/Investigator# 132628, MD
1290
mi
from
New York, NY
Click here to add this to my saved trials
1290
mi
from
New York, NY
Click here to add this to my saved trials
Newark, New Jersey
Principal Investigator: Site Reference ID/Investigator# 132638, MD
1278
mi
from
Newark, NJ
Click here to add this to my saved trials
Newport News, Virginia 23601
Principal Investigator: Site Reference ID/Investigator# 132634, MD
1170
mi
from
Newport News, VA
Click here to add this to my saved trials
Novi, Michigan 48377
Principal Investigator: Site Reference ID/Investigator# 132610, MD
824
mi
from
Novi, MI
Click here to add this to my saved trials
Orlando, Florida 32804
Principal Investigator: Site Reference ID/Investigator# 132614, MD
1139
mi
from
Orlando, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania
Principal Investigator: Site Reference ID/Investigator# 132625, MD
1225
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona
Principal Investigator: Site Reference ID/Investigator# 130755, MD
853
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania
Principal Investigator: Site Reference ID/Investigator# 132630, MD
971
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Oregon
Principal Investigator: Site Reference ID/Investigator# 130739, MD
1383
mi
from
Portland, OR
Click here to add this to my saved trials
Providence, Rhode Island
Principal Investigator: Site Reference ID/Investigator# 132642, MD
1424
mi
from
Providence, RI
Click here to add this to my saved trials
1424
mi
from
Providence, RI
Click here to add this to my saved trials
Rochester, New York
Principal Investigator: Site Reference ID/Investigator# 132620, MD
1122
mi
from
Rochester, NY
Click here to add this to my saved trials
Sacramento, California 95825
Principal Investigator: Site Reference ID/Investigator# 132602, MD
1278
mi
from
Sacramento, CA
Click here to add this to my saved trials
San Antonio, Texas 78224
Principal Investigator: Site Reference ID/Investigator# 131529, MD
583
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California
Principal Investigator: Site Reference ID/Investigator# 132601, MD
1143
mi
from
San Diego, CA
Click here to add this to my saved trials
1143
mi
from
San Diego, CA
Click here to add this to my saved trials
1143
mi
from
San Diego, CA
Click here to add this to my saved trials
1143
mi
from
San Diego, CA
Click here to add this to my saved trials
1143
mi
from
San Diego, CA
Click here to add this to my saved trials
1143
mi
from
San Diego, CA
Click here to add this to my saved trials
San Francisco, California
Principal Investigator: Site Reference ID/Investigator# 132600, MD
1339
mi
from
San Francisco, CA
Click here to add this to my saved trials
1339
mi
from
San Francisco, CA
Click here to add this to my saved trials
Seattle, Washington 98105
Principal Investigator: Site Reference ID/Investigator# 132637, MD
1410
mi
from
Seattle, WA
Click here to add this to my saved trials
Shreveport, Louisiana 71103
Principal Investigator: Site Reference ID/Investigator# 130733, MD
429
mi
from
Shreveport, LA
Click here to add this to my saved trials
St. Louis, Missouri 63104
Principal Investigator: Site Reference ID/Investigator# 132599, MD
417
mi
from
St. Louis, MO
Click here to add this to my saved trials
St. Paul, Minnesota 55114
Principal Investigator: Site Reference ID/Investigator# 132639, MD
552
mi
from
St. Paul, MN
Click here to add this to my saved trials