A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C

In brief

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 chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).

Key facts

Study ID

NCT00980330

Run by

Tibotec Pharmaceuticals, Ireland

People needed

463

Starts

2009-10-01

Expected to finish

2011-08-01

Last updated by the study team

2014-06-09

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Laurel, Maryland, United States
• Study site — Jackson, Mississippi, United States
• Study site — Tupelo, Mississippi, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Germantown, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — San Antonio, Texas, United States
• Study site — Concord, Australia
• Study site — Darlinghurst, Australia
• Study site — Fitzroy, Australia
• Study site — Melbourne, Australia
• Study site — New Lambton Heights, Australia
• Study site — Parkville, Australia
• Study site — Sydney, Australia
• Study site — Woolloongabba, Australia
• Study site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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