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TMC435-TiDP16-C206: A Safety and Efficacy Study in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

2014-08-27 03:19:12 | BioPortfolio

Summary

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 patients with chronic, genotype 1, hepatitis C who have failed previous treatment with pegylated interferon (Peg-INF) and ribavirin (RBV).

Description

The study is a randomized (study drug assigned by chance), double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled Phase IIb trial with TMC435 in patients with chronic, genotype 1, hepatitis C who have failed standard treatment with pegylated interferon (Peg-INF) and ribavirin (RBV). The study will compare the efficacy, tolerability and safety of different regimens with TMC435 combined with standard treatment (Peg-INF and RBV) versus standard treatment alone. The trial will consist of a screening period of maximum 6 weeks, a 48-week treatment period, and a 24-week follow-up period. Patients will be eligible to enroll in the trial if they failed to respond to a prior course of standard treatment or relapsed following standard treatment. Treatment arms 1 and 2 will receive TMC435 with standard treatment for 12 weeks; followed by standard treatment (plus placebo) for 36 weeks. Treatment arms 3 and 4 will receive TMC435 (100 mg or 150 mg once a day) with standard treatment for 24 weeks; followed by standard treatment (plus placebo) for 24 weeks. Treatment arms 5 and 6 will receive TMC435 (100 mg or 150 mg once a day) with standard treatment for 48 weeks. Treatment arm 7 (control arm) will receive standard treatment for 48 weeks. TMC435 (either 100 mg or 150 mg) will be given by mouth once a day for either 12, 24 or 48 weeks. Placebo will be given by mouth once a day for either 24, 36 or 48 weeks. Peg-INF will be given as an injection under the skin at a dose of 180 mcg once every week for 48 weeks. RBV (either 1000 or 1200 mg, depending on your body weight) will be given by mouth twice a day for 48 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Hepatitis C

Intervention

TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo, TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo, TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo, TMC435 /Peg IFNa2A/Ribavirin, TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo, TMC435 /Peg IFNa2A/Ribavirin, TMC435 placebo

Status

Active, not recruiting

Source

Tibotec Pharmaceuticals, Ireland

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:12-0400

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Medical and Biotech [MESH] Definitions

A nucleoside antimetabolite antiviral agent that blocks nucleic acid synthesis and is used against both RNA and DNA viruses.

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