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)
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Lead
AbbVie (prior sponsor, Abbott)
This was a Phase 2a multicenter, open-label, single arm, combination treatment study of a regimen of ABT-450/r/ABT-072, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-(1a or 1b) infected treatment-naïve participants.
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 be 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.
Clareo Health | 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)
