Clareo Health | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
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Lead
AbbVie (prior sponsor, Abbott)
This was a phase 2a multicenter, open-label, sequential, 3-arm, combination treatment study of a regimen of ABT-450/r/ABT-333, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected treatment-naïve participants and previous non-responders to pegylated interferon (pegIFN)/RBV treatment.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Chronic hepatitis C virus (HCV)
Treatment naive, null or partial responders to previous treatment with peginterferon and ribavirin
Males and females 18-65 years old
Body mass index 18 to \< 35 kg/m\^2
Females must be postmenopausal for at least 2 years or surgically sterile
You may not be if
Cirrhosis or extensive bridging fibrosis
History of cardiac disease
Positive screen for certain drugs or alcohol
Abnormal laboratory results
Significant sensitivity to any drug
Positive hepatitis B surface antigen or anti-human immunodeficiency virus 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
