Status:
COMPLETED
A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate effectiveness, safety and pharmacokinetics (Explores what the body does to the medication) of TMC435350 in combination with Peginterferon Alfa-2a and Ribavirin...
Detailed Description
This is a Phase 2, randomized (The study medication is assigned by chance.), 5-arm, open label (All people know the identity of the intervention.), multicentre (study conducted at multiple sites) stud...
Eligibility Criteria
Inclusion
- Participants with documented chronic hepatitis C infection as evidenced by presence of HCV antibody at least 6 months (180 days) prior to the informed consent. - Participants with genotype 1 HCV infection. - Participants with plasma HCV RNA level of ≥ 5.0 log10 IU/mL at screening.
Exclusion
- Participants diagnosed with hepatic cirrhosis or hepatic failure. - Participants with any other liver disease than hepatitis C. - Participants with infection/co-infection with non-genotype 1 HCV.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00996476
Start Date
July 1 2009
End Date
January 1 2011
Last Update
April 17 2014
Active Locations (19)
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1
Amagasaki, Japan
2
Hiroshima, Japan
3
Kagoshima, Japan
4
Kawasaki, Japan