A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)
Completed · Phase 2
Conditions studied: Hepatitis C, HCV, Chronic Hepatitis C Infection, Hepatitis C Genotype 1
In brief
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.
Key facts
- Study ID
- NCT01221298
- Run by
- AbbVie (prior sponsor, Abbott)
- People needed
- 11
- Starts
- 2010-10-01
- Expected to finish
- 2012-04-01
- 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, genotype 1 infection with interleukin 28B (IL28B) rs12979860 genotype C/C.
- Liver biopsy within 3 years with histology consistent with hepatitis C virus (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 postmenopausal for at least 2 years or surgically sterile.
- Be in a condition of general good health, as perceived by the investigator, other than hepatitis C virus infection.
- Body mass index 18 to < 35 kg/m\^2 .
You may not qualify if…
- Significant sensitivity to any drug.
- Use of herbal supplements within 2 weeks prior to study drug dosing.
- Positive screen for certain drugs or alcohol.
- Positive hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) antibody.
- Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing.
- Prior treatment with any investigational or commercially available anti-hepatitis C virus agents.
- Abnormal laboratory tests.
- Cirrhosis or extensive bridging fibrosis.
- History of cardiac disease.
Where it is running
- Site Reference ID/Investigator# 41128 — Los Angeles, California, United States
- Site Reference ID/Investigator# 42262 — Chicago, Illinois, United States
- Site Reference ID/Investigator# 41127 — San Antonio, Texas, United States
- Site Reference ID/Investigator# 43182 — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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