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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatitis C

In brief

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 regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.

Key facts

Study ID

NCT01485991

Run by

Janssen R&D Ireland

People needed

771

Starts

2012-02-01

Expected to finish

2014-04-01

Last updated by the study team

2016-04-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — San Diego, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Jacksonville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Chicago, Illinois, United States
• Study site — Crestview Hills, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Chevy Chase, Maryland, United States
• Study site — Jackson, Mississippi, United States
• Study site — Tupelo, Mississippi, United States
• Study site — Kansas City, Missouri, United States
• Study site — Missoula, Montana, United States
• Study site — Newark, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Allentown, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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