TMC435350-TiDP16-C202: A Study to Assess the Activity of TMC435 on Hepatitis C Virus in Patients Who Have Never Received Treatment for Their Hepatitis C Infection.
The primary objective of this study is to assess the activity of TMC435 on hepatitis C virus genotype 2, 3, 4, 5 and 6 replication when administered for 7 days to patients who have never been treated for their hepatitis C infection. This is an exploratory study. Viral kinetics, safety and pharmacokinetic / pharmacodynamic relationship will be studied.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Trial in Genotype 2, 3, 4, 5 and 6 Hepatitis C-infected Subjects to Evaluate the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 Following 7 Days Once Daily Dosing as Monotherapy.|
- Determine the antiviral effect of TMC435 during 7 days once daily dosing at 200mg orally (by mouth) as monotherapy in treatment naïve, genotype 2 to 6 HCV-infected patients.
- Determine the safety, tolerability and PK profile of TMC435 during 7 days once daily dosing at 200mg as monotherapy in treatment naïve, genotype 2 to 6 HCV-infected patients.
|Study Start Date:||February 2009|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
This is an open-label, phase IIa study to assess the activity of TMC435 in patients who have never been treated for their hepatitis C infection. The study consists of a screening period of maximum 6 weeks, a treatment period of 7 days and a follow-up period of 4 weeks. A total of 40 HCV-infected patients who have never been treated for HCV (8 patients per HCV genotype) will be enrolled in the study. All patients will receive TMC435 200mg once daily orally (by mouth) for 7 days. Subsequently, they can continue with Standard of Care (SoC) treatment consisting of pegylated interferon and ribavirin upon agreement with the study doctor. The SoC will be given outside the scope of this study. The primary objective in the study is to determine the antiviral activity of TMC435 when administered as monotherapy to treatment naïve, genotype 2 to 6 HCV-infected patients at a daily dose of 200mg orally (by mouth) for 7 days. During the treatment period, all patients will be assessed on a daily basis until 4 days following the last intake of TMC435. HCV viral load quantification and safety / tolerability assessments will be performed. Virologic and pharmacokinetic (PK) assessments for pharmacokinetic / pharmacodynamic analyses will be performed during the investigational treatment period. TMC435 200 mg once daily orally (by mouth) for 7 days as monotherapy