Status:
COMPLETED
A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chroni...
Detailed Description
The study is a randomized (study drug assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled Phase IIb trial with TMC435 in parti...
Eligibility Criteria
Inclusion
- Must have chronic hepatitis C infection as evidenced by liver biopsy, anti-hepatitis C virus (HCV) and HCV RNA positive
- Must have chronic hepatitis C infection (genotype 1) with HCV RNA level greater than10000 IU/mL
- Patient must have failed at least 1 prior course of peg interferon (Peg-IFN-alfa-2a)/ribavirin (RBV) therapy (standard treatment)
- Must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Exclusion
- Has an evidence of decompensated liver disease
- Co-infection with any other Hepatitis C virus genotype or co-infection with the human immunodeficiency virus (HIV)
- Has a medical condition which is a contraindication to Peg-INF or RBV therapy
- Have had history of, or any current medical condition which could impact the safety of the patient in the study
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
463 Patients enrolled
Trial Details
Trial ID
NCT00980330
Start Date
October 1 2009
End Date
August 1 2011
Last Update
June 9 2014
Active Locations (78)
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1
La Jolla, California, United States
2
Los Angeles, California, United States
3
Jacksonville, Florida, United States
4
Miami, Florida, United States