NCT01074008
A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072
Sponsored by AbbVie (prior sponsor, Abbott)
This study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072 in hepatitis C virus (HCV), genotype 1-infected, treatment-naïve adults.
Inclusion Criteria: * Chronic hepatitis C virus (HCV), genotype 1 infection (HCV ribonucleic acid level greater than or equal to 100,000 IU/mL) at screening * Liver biopsy within 3 years with histology consistent with HCV-induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV * Treatment naïve male or female between the ages of 18 and 65 * Females must be post-menopausal for more than 2 years or surgically sterile * Negative screen for drugs and alcohol * Negative hepatitis B surface antigen (HBsAg) and anti-human immunodeficiency virus antibodies (anti-HIV Ab) * No use of cytochrome P450 3A (CYP3A) and cytochrome P450 2C8 (CYP2C8) enzyme inducers or inhibitors within 1 month of dosing * Be in a condition of general good health, as perceived by the investigator, other than HCV infection Exclusion Criteria: * Significant sensitivity to any drug * Use of herbal supplements within 2 weeks prior to study drug dosing * History of major depression within 2 years * Prior treatment with any investigational or commercially available anti-HCV agents * Abnormal laboratory tests
Site Reference ID/Investigator# 23392
Phoenix, Arizona, United States
Site Reference ID/Investigator# 23370
Anaheim, California, United States
Site Reference ID/Investigator# 23387
La Jolla, California, United States
Site Reference ID/Investigator# 23388
Los Angeles, California, United States
Site Reference ID/Investigator# 23371
Aurora, Colorado, United States
Site Reference ID/Investigator# 23369
Orlando, Florida, United States
Site Reference ID/Investigator# 26362
Orlando, Florida, United States
Site Reference ID/Investigator# 23373
Chicago, Illinois, United States
Site Reference ID/Investigator# 24908
Chicago, Illinois, United States
Site Reference ID/Investigator# 23381
Indianapolis, Indiana, United States
Site Reference ID/Investigator# 23372
Baton Rouge, Louisiana, United States
Site Reference ID/Investigator# 24710
New Orleans, Louisiana, United States
Site Reference ID/Investigator# 23391
Baltimore, Maryland, United States
Site Reference ID/Investigator# 23377
Detroit, Michigan, United States
Site Reference ID/Investigator# 24909
Saint Paul, Minnesota, United States
Site Reference ID/Investigator# 35842
New York, New York, United States
Site Reference ID/Investigator# 23379
New York, New York, United States
Site Reference ID/Investigator# 23375
Chapel Hill, North Carolina, United States
Site Reference ID/Investigator# 23385
Durham, North Carolina, United States
Site Reference ID/Investigator# 23376
Dallas, Texas, United States
Site Reference ID/Investigator# 24891
Houston, Texas, United States
Site Reference ID/Investigator# 23382
San Antonio, Texas, United States
Site Reference ID/Investigator# 24715
Salt Lake City, Utah, United States
Site Reference ID/Investigator# 25463
Seattle, Washington, United States
Site Reference ID/Investigator# 23383
Madison, Wisconsin, United States
Site Reference ID/Investigator# 23363
Ponce, Puerto Rico
Identity-resolution confidence concerns registry/entity resolution and does not determine clinical eligibility.
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