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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C

In brief

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 patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA \[less than 25 IU per mL undetectable\] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.

Key facts

Study ID

NCT00882908

Run by

Tibotec Pharmaceuticals, Ireland

People needed

386

Starts

2009-06-01

Expected to finish

2011-04-01

Last updated by the study team

2014-06-16

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Jacksonville, 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 — Saint Paul, Minnesota, 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 — Charlottesville, Virginia, United States
• Study site — Concord, Australia
• Study site — Darlinghurst, Australia
• Study site — Fitzroy, Australia
• Study site — Melbourne, Australia
• Study site — Sydney, Australia
• Study site — Woolloongabba, Australia
• Study site — Vienna, Austria
• Study site — Bruges, Belgium
• Study site — Brussels, Belgium
• Study site — Edegem, Belgium
• Study site — Ghent, Belgium
• Study site — Leuven, Belgium
• Study site — Roeselare, Belgium
• Study site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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