Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hepatitis C
Pharmacokinetics
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
Brief Summary
The current Standard of Care (SOC) for chronic HCV infection, which is pegylated interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is effective in only part of the pa...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- chronic HCV genotype-1;
- high viral load
- Exclusion criteria:
- Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening
- Previous treatment with protease inhibitor
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00947349
Start Date
July 1 2009
End Date
August 1 2011
Last Update
July 7 2015
Active Locations (3)
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1
1220.14.003 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama, Japan
2
1220.14.001 Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo, Japan
3
1220.14.002 Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo, Japan