Tracking Information
Start Date ICMJE | July 2009 |
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Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: May 28, 2009) | Time to sputum culture conversion in MGIT during and beyond treatment with TMC207. Sputum culture conversion will be defined as 2 consecutive negative cultures from sputa collected at least 28 days apart. [ Time Frame: During 17 visits over 100 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00910871 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: May 28, 2009) | To evaluate the pharmacokinetics of TMC207 and its primary metabolite M2, and pharmacokinetic/pharmacodynamic relationships for safety and efficacy. [ Time Frame: 7 visits during treatment period of 24 weeks ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | TMC207-TiDP13-C209 Trial to Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Patients With Sputum Smear-positive Pulmonary MDR-TB. |
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Official Title ICMJE | A Phase II, Open-label Trial With TMC207 as Part of a Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Subjects With Sputum Smear-positive Pulmonary Infection With MDR-TB. |
Brief Summary | The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB |
Detailed Description | This is a Phase II, open-label (all people involved know the identity of the intervention) trial to evaluate the safety, tolerability, and efficacy of TMC207 as part of an individualized Multi-drug Resistant Tuberculosis (MDR-TB) treatment regimen in patients with sputum smear-positive pulmonary MDR-TB. Approximately 225 patients will receive TMC207 for 24 weeks in combination with an individualized background regimen (BR) of antibacterial drugs used in the treatment of TB according to national and international guidelines and selected at the baseline visit. TMC207 dosage will be 400 mg once daily (q.d.) for the first 2 weeks and 200 mg 3 times/week (t.i.w.) for the following 22 weeks. Upon completion of the 24-week treatment with TMC207, all patients will continue to receive their BR under the care of their physician and in accordance with national TB program (NTP) treatment guidelines. Additionally, the pharmacokinetics (how the body absorbs, distributes, metabolizes and eliminates a drug) of TMC207 and its N-monodesmethyl metabolite (M2), and pharmacokinetic/pharmacodynamic (the study of the action or effects a drug has on the body) relationships for safety and efficacy will be assessed. Safety evaluations that will be performed are lab tests, vital signs, ECG, reporting of adverse events, physical examinations and X-rays. All patients will be followed up for 19 months after their last intake of TMC207. Also patients who prematurely withdraw (unless they withdraw consent) will be followed for this period or until the last follow-up visit for the last patient in the trial. Investigators will be asked to provide information about the survival/clinical outcome of these patients throughout the follow-up period, approximately every 6 months. Primary outcome is time to sputum culture conversion in Mycobacteria Growth Indicator Tube (MGIT) during and beyond treatment with TMC207. Sputum culture conversion will be defined as 2 consecutive negative cultures from sputa collected at least 28 days apart. TMC207 will be dosed as 400 mg once daily for the first 2 weeks and 200 mg 3 times/ week for the following 22 weeks, on top of a background regimen. |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Condition ICMJE | Tuberculosis |
Intervention ICMJE | Drug: TMC207 400mg qd X 2wks then 200mg tiw X 22wks+individualized BR of antibacterial drugs |
Study Arms / Comparison Groups | 001: Experimental TMC207 400mg qd X 2wks then 200mg tiw X 22wks+individualized BR of antibacterial drugs Intervention: Drug: TMC207 |
Recruitment Information
Estimated Enrollment ICMJE | 225 | ||||
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Estimated Completion Date | June 2012 | ||||
Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Brazil, China, Estonia, Kenya, Korea, Republic of, Latvia, Peru, Philippines, Russian Federation, South Africa, Thailand, Turkey, Ukraine |
Administrative Information
NCT ID ICMJE | NCT00910871 | ||||
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Responsible Party | Compound Development Team Leader, Tibotec Pharmaceuticals, Ireland | ||||
Study ID Numbers ICMJE | CR012352, TMC207-TiDP13-C209 | ||||
Study Sponsor ICMJE | Tibotec-Virco Virology BVBA | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Tibotec-Virco Virology BVBA |