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Safety and PK of ABT-267 in HCV Genotype 1
NCT01563536Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2012
- Primary completion
- Apr 2012
- Countries
- 1
- Sponsor
- AbbVie Inc.
- Modality
- Small Molecules
- Drugs
- ombitasvir
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 2, open-label trial of ombitasvir in hepatitis C (HCV) (2 cohorts), sponsored by AbbVie Inc. Primary endpoints: Maximum Plasma Concentration at Day 2, Time of Maximum Plasma Concentration at Day 2 and 4 more. Started Feb 2012; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
1.5 mg Cohort
ABT-267 1.5 mg lead-in then combination
25 mg Cohort
ABT-267 25 mg lead-in then combination
03
Who it enrols
Treatment-naive adults with chronic HCV genotype 1 infection, without cirrhosis.
04
Endpoints
Primary
Maximum Plasma Concentration
Time of Maximum Plasma Concentration
Area Under the Plasma Concentration-time Curve
Plasma Concentration Pre-dose
Number of Participants With Adverse Events
Secondary
Sustained Virologic Response 12 Weeks After Combination Therapy
Sustained Virologic Response 24 Weeks After Combination Therapy
Rapid Virologic Response
End-of-Treatment Response
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