Status:
COMPLETED
A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received 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 evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patient...
Detailed Description
This is a randomized (study medication assigned by chance), 5-arm, double-blind (neither investigator nor the participant knows the treatment that the participant receives), placebo-controlled (an ina...
Eligibility Criteria
Inclusion
- Patients with documented chronic genotype-1 hepatitis C infection and with plasma HCV RNA of \> 100,000 IU/mL at screening
- Patients that have not been treated before for HCV
- Patients that are of childbearing potential or have a partner of childbearing potential should agree to use 2 effective methods of contraception
Exclusion
- Patients with cirrhosis or evidence of hepatic decompensation
- Co-infection with the human immunodeficiency virus (HIV)
- Any contraindication to Pegasys or Copegus therapy
- History of, or any current medical condition which could impact the safety of the patient in the study
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT00882908
Start Date
June 1 2009
End Date
April 1 2011
Last Update
June 16 2014
Active Locations (71)
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Los Angeles, California, United States
2
Jacksonville, Florida, United States
3
Orlando, Florida, United States
4
Palm Harbor, Florida, United States