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Phase 2 open-label extended early bactericidal activity study of TMC207 combinations in treatment-naive pulmonary tuberculosis
2004-005142-12Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2005
- Countries
- 1
- Sponsor
- Tibotec
- Modality
- Small Molecules
- Conditions
- pulmonary tuberculosis (TB)
01
Overview
Phase 2, open-label trial of bedaquiline, isoniazid, pyrazinamide and rifampicin in pulmonary tuberculosis (TB) (5 arms), sponsored by Tibotec. Primary endpoints: Extended early bactericidal activity at 14 days and Recommendation of treatment combinations for future trials. Started Feb 2005; status: completed.
02
Design
5 arms- Study design
- Open-label
TMC207 + isoniazid
TMC207 oral solution combined with isoniazid for 14 days
TMC207 + pyrazinamide
TMC207 oral solution combined with pyrazinamide for 14 days
TMC207 + rifampin
TMC207 oral solution combined with rifampin for 14 days
TMC207 + isoniazid + pyrazinamide
TMC207 oral solution combined with isoniazid and pyrazinamide for 14 days
HRZ standard therapy
Isoniazid, rifampin, and pyrazinamide standard anti-tuberculosis therapy for 14 days
03
Who it enrols
Treatment-naive male or female patients with sputum smear-positive pulmonary tuberculosis were eligible. Women had to be of non-childbearing potential or use effective non-hormonal contraception and continue it for at least 14 days after the study period; patients with known or suspected hypersensitivity or serious adverse reactions to study drugs, including rifamycins, were excluded.
04
Endpoints
Primary
Extended early bactericidal activity at 14 days
Recommendation of treatment combinations for future trials
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