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Sponsored by: |
Tibotec Pharmaceuticals Limited, Ireland |
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Information provided by: | Tibotec Pharmaceuticals Limited, Ireland |
ClinicalTrials.gov Identifier: | NCT00812331 |
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.
Condition | Intervention | Phase |
---|---|---|
Hepatitis C Infection Hepatitis C, Chronic |
Drug: TMC435 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 40 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | November 2009 |
Estimated 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
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Belgium | |
Recruiting | |
Brugge, Belgium | |
Recruiting | |
Bruxelles, Belgium | |
Recruiting | |
Brussels, Belgium | |
Recruiting | |
Gent, Belgium | |
Recruiting | |
Leuven, Belgium | |
Germany | |
Active, not recruiting | |
Freiburg, Germany | |
Recruiting | |
Frankfurt N/A, Germany | |
Recruiting | |
Berlin, Germany | |
Recruiting | |
Hannover, Germany | |
Thailand | |
Recruiting | |
Bangkok, Thailand | |
Recruiting | |
Chiang Mai, Thailand |
Study Director: | Tibotec Pharmaceuticals Limited Clinical Trial | Tibotec Pharmaceutical Limited |
Responsible Party: | Tibotec Pharmaceuticals Limited ( Compound Development Team Leader ) |
Study ID Numbers: | CR012604 |
Study First Received: | December 18, 2008 |
Last Updated: | August 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00812331 History of Changes |
Health Authority: | Ireland: Irish Agriculture and Food Development Authority |
TMC435350-TiDP16-C202 TMC435350-C202 TMC435 |
Hepatitis Hepatitis C Tibotec |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Hepatitis, Viral, Human Hepatitis C Antiviral Agents Hepatitis C, Chronic |
Virus Diseases Hepatitis Communicable Diseases RNA Virus Infections Liver Diseases Digestive System Diseases |
Hepatitis, Chronic Flaviviridae Infections Hepatitis, Viral, Human Hepatitis C Infection Hepatitis C, Chronic |