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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00449644 |
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Date of registration:
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16/03/2007 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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). |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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208 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00449644 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Brazil
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China
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India
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Kenya
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Latvia
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Lithuania
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Peru
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Philippines
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Russian Federation
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South Africa
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Thailand
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Uganda
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Contacts
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Name:
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Janssen Infectious Diseases BVBA Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Infectious Diseases BVBA |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Females of non-childbearing potential
- Patients with newly diagnosed sputum smear-positive pulmonary MDR-TB infection
- Patients must consent to HIV-testing
- Patients must be willing to discontinue all TB drugs to allow 7 days washout
- Patients having normal weight
- Patients are willing to be hospitalized per standard of care.
Exclusion Criteria:
- Previously having been treated for MDR-TB
- Having a significant cardiac arrhythmia that requires medication
- For HIV infected patients, having a CD4+ count < 300 cells/µL
- Patients with complicated or severe extrapulmonary manifestations of TB or
neurological manifestations of TB
- Patients who will require surgical procedure for management of their TB
- Evidence of chorioretinitis, optic neuritis, or uveitis at screening
- Having had a drug susceptibility test performed prior to screening and being not
susceptible to at least 3 of the 5 classes of TB drugs used to treat MDR-TB
- Women who are pregnant and/or breastfeeding.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tuberculosis
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Intervention(s)
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Drug: Placebo
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Drug: TMC207
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Primary Outcome(s)
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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.]
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Secondary Outcome(s)
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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.]
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Secondary ID(s)
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CR011929
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TMC207-TIDP13-C208
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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