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NCT00910871 - 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

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

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Data Specification

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Annotated CRF

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Product Info

Generic Name
Bedaquiline/TMC207
Product Name
SIRTURO®
Therapeutic Area
Respiratory Tract (Lung and Bronchial) Diseases
Enrollment
241
Product Class
Antimycobacterial agents
Sponsor Protocol Number
CR012352, TMC207-TiDP13-C209, 2008-008444-25
Data Holder
Johnson & Johnson
Condition Studied
Tuberculosis

Supporting Documentation

Analysis Datasets
Annotated Case Report Form (CRF)
Collected Datasets
Data Definition Specification
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
2

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.