A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection



Status:Active, not recruiting
Conditions:Infectious Disease, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 99
Updated:10/26/2018
Start Date:June 12, 2014
End Date:May 5, 2020

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Trial Summary
Trial Overview
Inclusion Criteria

An Open-Label, Multicenter Study to Evaluate Long-term Outcomes With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ II)

The purpose of this study is to evaluate Long-term Outcomes following treatment with
ABT-450/r/ABT-267, ABT-333 with or without RBV in Adults With Genotype 1 Chronic Hepatitis C
Virus (HCV) Infection


Inclusion Criteria:

1. Females must be post-menopausal for more than 2 years or surgically sterile or
practicing specific forms of birth control

2. Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 1,000 IU/mL at
screening)

3. HCV genotype 1 infection per screening laboratory result

Exclusion Criteria:

1. Use of contraindicated medications within 2 weeks of dosing

2. Abnormal laboratory tests

3. Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody

4. Clinical history of liver decompensation

5. Presence of hepatocellular carcinoma at screening
We found this trial at
48
sites
Icahn School of Med Mt. Sinai /ID# 128682
New York, New York 10029
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University of New Mexico /ID# 128859
Albuquerque, New Mexico 87131
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Albuquerque, NM
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Atlanta Gastro Assoc /ID# 126571
Atlanta, Georgia 30308
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Atlanta, GA
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University of Colorado Cancer Center /ID# 126568
Aurora, Colorado 80045
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Aurora, CO
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Austin Center for Clinical Res /ID# 126562
Austin, Texas 78756
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Austin, TX
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Felizarta /ID# 126569
Bakersfield, California 93301
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Bakersfield, CA
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Johns Hopkins University /ID# 127791
Baltimore, Maryland 21287
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Baltimore, MD
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Inquest Clinical Research /ID# 126574
Baytown, Texas 77521
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Baytown, TX
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Beth Israel Deaconess Medical Center /ID# 126560
Boston, Massachusetts 02215
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Boston, MA
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Bach and Godofsky Infec Dis /ID# 128685
Bradenton, Florida 34209
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Bradenton, FL
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Digestive Disease Associates, PA /ID# 127624
Catonsville, Maryland 21228
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Catonsville, MD
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Carolinas Medical Center /ID# 127632
Charlotte, North Carolina 28204
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Charlotte, NC
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Northwestern University /ID# 128684
303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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University of Chicago /ID# 126576
Chicago, Illinois 60637
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Chicago, IL
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University of Cincinnati /ID# 127790
Cincinnati, Ohio 45267
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Cincinnati, OH
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Henry Ford Health System /ID# 127783
Detroit, Michigan 48202
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Detroit, MI
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AGA Clinical Research Associates, LLC /ID# 126578
Egg Harbor Township, New Jersey 08234
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Egg Harbor Township, NJ
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University of Florida /ID# 127787
1600 Southwest Archer Road
Gainesville, Florida 32610
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Gainesville, FL
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Gastro One /ID# 127792
1324 Wolf Park Drive
Germantown, Tennessee 38138
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Germantown, TN
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Cure C Consortium /ID# 126570
Houston, Texas 77004
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Houston, TX
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Liver Associates of Texas, P.A. /ID# 126563
6410 Fannin Street
Houston, Texas 77030
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Houston, TX
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Indiana University Health /ID# 126573
Indianapolis, Indiana 46202
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Indianapolis, IN
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Borland-Groover Clinic /ID# 127781
4800 Belfort Road
Jacksonville, Florida 32256
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Jacksonville, FL
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Ruane Clinical Research Group Inc. /ID# 126577
5901 West Olympic Boulevard
Los Angeles, California 90036
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Los Angeles, CA
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Dean Clinic /ID# 126575
1225 Fish Hatchery Road
Madison, Wisconsin 53715
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Madison, WI
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University of Miami /ID# 127622
Miami, Florida 33136
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Miami, FL
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Clinical Research Ctrs America /ID# 127780
Murray, Utah 84123
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Murray, UT
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North Shore University Hospital /ID# 126565
New Hyde Park, New York 11040
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New Hyde Park, NY
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Tulane University /ID# 127779
1415 Tulane Avenue
New Orleans, Louisiana 70112
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New Orleans, LA
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Columbia University Medical Center /ID# 126566
New York, New York 10032
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New York, NY
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Columbia Univ Medical Center /ID# 127621
New York, New York 10032
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New York, NY
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New Jersey Medical School /ID# 128686
Newark, New Jersey 07103
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Newark, NJ
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St. Josephs Hospital and Medical Center /ID# 127800
350 West Thomas Road
Phoenix, Arizona 85013
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Phoenix, AZ
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Minnesota Gastroenterology, PA /ID# 126579
Plymouth, Minnesota 55446
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Plymouth, MN
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Premier Medical Group /ID# 127793
Poughkeepsie, New York 12601
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Poughkeepsie, NY
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University Gastroenterology /ID# 127789
33 Staniford Street
Providence, Rhode Island 02905
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Providence, RI
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University of Rochester Medical Center /ID# 127655
601 Elmwood Avenue
Rochester, New York 14642
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Rochester, NY
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Saint Louis University School of Medicine /ID# 126564
Saint Louis, Missouri 63104
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Saint Louis, MO
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TX Liver Inst, Americ Res Corp /ID# 127623
San Antonio, Texas 78215
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San Antonio, TX
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California Pacific Medical Ctr /ID# 128681
San Francisco, California 94115
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San Francisco, CA
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Southwest Care Center /ID# 127784
649 Harkle Road
Santa Fe, New Mexico 87505
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Santa Fe, NM
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Virginia Mason Medical Center /ID# 130288
1100 9th Avenue
Seattle, Washington 98101
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Seattle, WA
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University of Washington /ID# 127785
908 Jefferson Street
Seattle, Washington 98104
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Seattle, WA
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Louisiana Research Center, LLC /ID# 126561
1800 East 70th Street
Shreveport, Louisiana 71105
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Shreveport, LA
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Carolinas Center For Liver Dis /ID# 127788
Statesville, North Carolina 28677
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Statesville, NC
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Options Health Research, LLC /ID# 127630
Tulsa, Oklahoma 74104
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Tulsa, OK
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MedStar Washington Hosp Ctr /ID# 128683
Washington, District of Columbia 20010
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Washington,
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South Florida Ctr Gastro, P.A. /ID# 126567
Wellington, Florida 33414
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Wellington, FL
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