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NCT00523926 - An Open-label Study to Evaluate the Extended Early Bactericidal Activity, Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of TMC207 in Treatment-naive Subjects With Sputum Smear Positive Pulmonary Tuberculosis.

An Open-label Study to Evaluate the Extended Early Bactericidal Activity, Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of TMC207 in Treatment-naive Subjects With Sputum Smear Positive Pulmonary Tuberculosis.


CSR Summary

Not Available


Data Specification

Not Available


Annotated CRF

Not Yet Available

Product Info

Generic Name
Bedaquiline/TMC207
Product Name
SIRTURO®
Therapeutic Area
Respiratory Tract (Lung and Bronchial) Diseases
Enrollment
75
% Female
N/A
% White
N/A
Product Class
Antimycobacterial Agents
Sponsor Protocol Number
TMC207-C202
Data Partner
Condition Studied
Tuberculosis
Mean/Median Age (Years)
N/A

Supporting Documentation

Clinical Study Report
Collected Datasets
Annotated Case Report Form
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.