Status:
COMPLETED
Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects
Lead Sponsor:
Akros Pharma Inc.
Conditions:
Hepatitis C Virus Infection, Response to Therapy of
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study was to determine the safety, tolerability, pharmacokinetics and anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on reduction in viral l...
Eligibility Criteria
Inclusion
- Males and females infected with chronic hepatitis C virus (HCV) infection and genotype 1a or 1b
- Subjects with a viral load (HCV RNA level) of ≥50,000 IU/mL
- Subjects with a body mass index (BMI) of 18.0-36.0 kg/m2 (inclusive)
Exclusion
- Subjects should not have previously received a direct acting anti-HCV agent
- Subjects should not previously have received pegylated interferon/ribavirin for a duration of more than two weeks
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01473056
Start Date
August 1 2010
End Date
September 1 2011
Last Update
November 21 2011
Active Locations (1)
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1
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, 00927