Status:
COMPLETED
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)
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Hepatitis C
HCV
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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) ...
Detailed Description
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 tr...
Eligibility Criteria
Inclusion
- 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 .
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01221298
Start Date
October 1 2010
End Date
April 1 2012
Last Update
January 8 2015
Active Locations (4)
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1
Site Reference ID/Investigator# 41128
Los Angeles, California, United States, 90048
2
Site Reference ID/Investigator# 42262
Chicago, Illinois, United States, 60637
3
Site Reference ID/Investigator# 41127
San Antonio, Texas, United States, 78215
4
Site Reference ID/Investigator# 43182
Seattle, Washington, United States, 98101