Clinical Trial Results:
An open-label study to evaluate the extended early bactericidal activity, safety, tolerability and pharmacokinetics of multiple doses (m.d.) of TMC207 oral solution (os) and isoniazid (JH), m.d. of TMC207 os and pyrazinamide (JZ), m.d. of TMC207 os and rifampin (JR) or m. oral d. of TMC207 os and isoniazid and pyrazinamide (JHZ), compared to the 3 principle drugs of standard anti-tuberculosis treatment (HRZ) in treatment-naïve subjects with sputum-smear positive pulmonary tuberculosis.
Summary
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EudraCT number |
2004-005142-12 |
Trial protocol |
GB |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Nov 2020
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First version publication date |
30 Nov 2020
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Other versions |
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Summary report(s) |
TMC207-C203_Results Statement |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.