Status:
COMPLETED
TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy
Lead Sponsor:
Janssen R&D Ireland
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved re...
Detailed Description
This study is a randomized (study drug assigned by chance like flipping a coin), double-blind (neither physician nor patient knows the name of the assigned drug), double-dummy (patients receive both a...
Eligibility Criteria
Inclusion
- Patient must have had a liver biopsy before screening (or between the screening and baseline visit), unless patient cannot undergo such a procedure or has evidence of portal hypertension not associated with cirrhosis. For patients who had a liver biopsy performed more than 2 years prior to screening or without a biopsy (because of a contraindication or portal hypertension), a non-invasive staging assessment needs to be available. Non-invasive staging assessments include FibroScan, MR-Elastography, or FibroTest/FibroSure and must not be older than 6 months prior to screening
- Chronicity of hepatitis C virus (HCV) infection, as confirmed by one or both of the following: presence of anti-HCV antibody and/or HCV ribonucleic acid (RNA) at least 6 months prior to the screening visit and/or presence of fibrosis on biopsy
- Genotype 1 HCV infection with plasma HCV RNA of \>10,000 IU/mL (both confirmed at screening)
- Patient must have had at least 1 documented previous course of treatment with PegINFα-2a or PegINFα-2b in combination with ribavirin (RBV) (at least 12 weeks for null responder and 20 weeks for partial responder)
Exclusion
- Hepatic decompensation (impaired functioning of the liver), as indicated by significant laboratory abnormalities or other active diseases
- Infection with Human Immunodeficiency Virus (HIV) or non genotype 1 hepatitis C
- Liver disease not related to hepatitis C infection
- Previous chronic hepatitis C treatment, other than PegIFN and RBV
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
771 Patients enrolled
Trial Details
Trial ID
NCT01485991
Start Date
February 1 2012
End Date
April 1 2014
Last Update
April 26 2016
Active Locations (137)
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1
Bakersfield, California, United States
2
San Diego, California, United States
3
Aurora, Colorado, United States
4
Washington D.C., District of Columbia, United States