A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C, HCV, Chronic Hepatitis C Infection, Hepatitis C Genotype 1

In brief

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.

Key facts

Study ID

NCT01074008

Run by

AbbVie (prior sponsor, Abbott)

People needed

74

Starts

2010-03-01

Expected to finish

2012-01-01

Last updated by the study team

2015-01-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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