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

Completed · Phase 3

Conditions studied: Chronic Hepatitis C Virus (HCV) Infection Genotype 1

In brief

The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.

Key facts

Study ID

NCT02167945

Run by

AbbVie

People needed

615

Starts

2014-06-12

Expected to finish

2021-05-13

Last updated by the study team

2022-07-19

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
• Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 1,000 IU/mL at screening)
• HCV genotype 1 infection per screening laboratory result

You may not qualify if…

• Use of contraindicated medications within 2 weeks of dosing
• Abnormal laboratory tests
• Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody
• History of solid organ transplant, clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation
• Presence of hepatocellular carcinoma at screening

Where it is running

• St. Josephs Hospital and Med Center /ID# 127800 — Phoenix, Arizona, United States
• Franco Felizarta, Md /Id# 126569 — Bakersfield, California, United States
• Ruane Clinical Research Group /ID# 126577 — Los Angeles, California, United States
• California Pacific Medical Center /ID# 128681 — San Francisco, California, United States
• Univ of Colorado Cancer Center /ID# 126568 — Aurora, Colorado, United States
• Medstar Health Research Institute /ID# 128683 — Washington D.C., District of Columbia, United States
• Bach and Godofsky Infec Dis /ID# 128685 — Bradenton, Florida, United States
• University of Florida - Archer /ID# 127787 — Gainesville, Florida, United States
• Encore Borland-Groover Clinical Research /Id# 127781 — Jacksonville, Florida, United States
• University of Miami /ID# 127622 — Miami, Florida, United States
• South Florida Ctr Gastro, P.A. /ID# 126567 — Wellington, Florida, United States
• Atlanta Gastro Assoc /ID# 126571 — Atlanta, Georgia, United States
• Northwestern University Feinberg School of Medicine /ID# 128684 — Chicago, Illinois, United States
• The University of Chicago Medical Center /ID# 126576 — Chicago, Illinois, United States
• Duplicate_Indiana University Health /ID# 126573 — Indianapolis, Indiana, United States
• Tulane University /ID# 127779 — New Orleans, Louisiana, United States
• Louisana Research Center, LLC /ID# 126561 — Shreveport, Louisiana, United States
• Johns Hopkins University /ID# 127791 — Baltimore, Maryland, United States
• Digestive Disease Associates - Catonsville /ID# 127624 — Catonsville, Maryland, United States
• Beth Israel Deaconess Medical Center /ID# 126560 — Boston, Massachusetts, United States
• Henry Ford Health System /ID# 127783 — Detroit, Michigan, United States
• Minnesota Gastroenterology PA /ID# 126579 — Plymouth, Minnesota, United States
• St. Louis University /ID# 126564 — St Louis, Missouri, United States
• AGA Clinical Research Associates, LLC /ID# 126578 — Egg Harbor, New Jersey, United States
• Rutgers New Jersey School of Medicine /ID# 128686 — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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