Tracking Information
Start Date ICMJE | May 2007 |
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Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: December 20, 2007) | The primary outcome parameter will be the time to sputum culture conversion during treatment with TMC207 or placebo [ Time Frame: Stage 1 consists of 8 week treatment period (11 visits). Stage II consists of 24 week treatment period (19 visits). All subjects will be followed for 96 weeks after last dose of TMC207 or placebo. ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE (submitted: March 16, 2007) |
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Change History | Complete list of historical versions of study NCT00449644 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: February 14, 2008) | Pharmacokinetics of TMC207 and its N-monodesmethyl metabolite (M2) in plasma and sputum, pharmacokinetic/pharmacodynamic relationships for activity and tolerability/safety, and drug-drug interactions between TMC207 and drugs in the BR will be assessed. [ Time Frame: Stage 1 consists of 8 week treatment period (11 visits). Stage II consists of 24 week treatment period (19 visits). All subjects will be followed for 96 weeks after last dose of TMC207 or placebo. ] [ Designated as safety issue: Yes ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Patients With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB). |
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Official Title ICMJE | A Phase II, Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Subjects With Newly Diagnosed Sputum Smear-positive Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB). |
Brief Summary | The objective of this study is to demonstrate that the antibacterial activity of TMC207 is better than placebo when added to a standardized Background Regimen (BR) for treatment of multi-drug resistant TB. Also safety and tolerability will be evaluated. |
Detailed Description | The trial will be conducted in 2 consecutive stages, an exploratory (investigative) stage (Stage 1) and a proof of effectiveness stage (Stage 2). During Stage 1, a panel of 50 patients will be randomized (patients are assigned different treatments based on chance) to receive either TMC207 or placebo for 8 weeks on top of a BR. In Stage 2, another panel of 150 patients will be randomized to receive either TMC207 or placebo for 24 weeks on top of a BR. TMC207 will be dosed as 400 mg every day for the first 2 weeks, and as 200 mg 3 times/week for the following 6 or 22 weeks during Stages 1 and 2, respectively.When the patients in Stage 1 have completed 8 weeks double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage) treatment with TMC207 or placebo (or have discontinued earlier), the primary Stage 1 analysis will be performed on all data of the first 8 weeks of treatment.Following this Stage 1 analysis, Stage 2 will be initiated and a panel of 150 new patients will be enrolled.The primary efficacy analysis will be performed on all Stage 2 patients when they have completed the 24-week double blind treatment with TMC207 or placebo (or have discontinued earlier). After the double-blind treatment phase in both Stage 1 and Stage 2, patients will continue to receive MDR-TB treatment as per national treatment guidelines. They will be followed for safety, tolerability, pharmacokinetics, and microbiological efficacy for 96 weeks after receiving their last dose of TMC207 or placebo. The Data Safety Monitoring Board Committee will review these data on a regular basis. The DSMB/DSMC is a group of experts in tuberculosis and clinical trial conduct who have no commercial interests in the development of TMC207 and the company (Tibotec, BVBA) that is developing the new TB drug. During Stage 1, a panel of 50 patients will be randomized to receive either TMC207 or placebo for 8 weeks on top of a BR. In Stage 2, another panel of 150 patients will be randomized to receive either TMC207 or placebo for 24 weeks on top of a BR. TMC207 will be dosed as 400 mg per day for the first 2 weeks, and as 200 mg 3 times/week |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Tuberculosis |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Publications * | Diacon AH, Pym A, Grobusch M, Patientia R, Rustomjee R, Page-Shipp L, Pistorius C, Krause R, Bogoshi M, Churchyard G, Venter A, Allen J, Palomino JC, De Marez T, van Heeswijk RP, Lounis N, Meyvisch P, Verbeeck J, Parys W, de Beule K, Andries K, Mc Neeley DF. The diarylquinoline TMC207 for multidrug-resistant tuberculosis. N Engl J Med. 2009 Jun 4;360(23):2397-405. |
Recruitment Information
Estimated Enrollment ICMJE | 200 | ||||
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Estimated Completion Date | February 2012 | ||||
Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Brazil, India, Latvia, Peru, Philippines, Russian Federation, South Africa, Thailand |
Administrative Information
NCT ID ICMJE | NCT00449644 | ||||
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Responsible Party | Compound Development Team Leader TMC207, Tibotec BVBA | ||||
Study ID Numbers ICMJE | CR011929, TMC207-TIDP13-C208 | ||||
Study Sponsor ICMJE | Tibotec-Virco Virology BVBA | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Tibotec-Virco Virology BVBA |