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Generated: December 9, 2018

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CLINICAL TRIALS PROFILE FOR SIRTURO

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Clinical Trials for Sirturo

Trial ID Title Status Sponsor Phase Summary
NCT02193776 A Phase 2 Open Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculos Active, not recruiting Global Alliance for TB Drug Development Phase 2 The purpose of this study is to determine the mycobactericidal activity of combinations of bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks of treatment.
NCT02409290 The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB Recruiting Medical Research Council Phase 3 Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. MDR-TB leads to a considerable reduction in the effectiveness of standard short-length treatments and currently the standard treatments for MDR-TB can last as long as 24 months. With the incident rate of MDR-TB on the rise (511,000 new cases in 2007) and the lengthy duration of current treatments there is a need to investigate whether a shorter-length treatment using effective drugs is a global possibility. Three short course regimens of drugs will be evaluated alongside the World Health Organisation recommended 24 month regimen for the treatment of MDR-TB. A total of at least 1155 participants with MDR-TB will be recruited and followed for a total of 132 weeks.
NCT02409290 The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB Recruiting IUATLD, Inc Phase 3 Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. MDR-TB leads to a considerable reduction in the effectiveness of standard short-length treatments and currently the standard treatments for MDR-TB can last as long as 24 months. With the incident rate of MDR-TB on the rise (511,000 new cases in 2007) and the lengthy duration of current treatments there is a need to investigate whether a shorter-length treatment using effective drugs is a global possibility. Three short course regimens of drugs will be evaluated alongside the World Health Organisation recommended 24 month regimen for the treatment of MDR-TB. A total of at least 1155 participants with MDR-TB will be recruited and followed for a total of 132 weeks.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Sirturo

Condition Name

Condition Name for Sirturo
Intervention Trials
Tuberculosis, Multidrug-Resistant 3
Tuberculosis 3
Extensively Drug-Resistant Tuberculosis 2
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Condition MeSH

Condition MeSH for Sirturo
Intervention Trials
Tuberculosis 6
Tuberculosis, Multidrug-Resistant 4
Tuberculosis, Pulmonary 3
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Clinical Trial Locations for Sirturo

Trials by Country

Trials by Country for Sirturo
Location Trials
South Africa 6
Georgia 2
Tanzania 1
Lesotho 1
Russian Federation 1
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Clinical Trial Progress for Sirturo

Clinical Trial Phase

Clinical Trial Phase for Sirturo
Clinical Trial Phase Trials
Phase 3 3
Phase 2/Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Sirturo
Clinical Trial Phase Trials
Active, not recruiting 2
Not yet recruiting 2
Recruiting 2
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Clinical Trial Sponsors for Sirturo

Sponsor Name

Sponsor Name for Sirturo
Sponsor Trials
Global Alliance for TB Drug Development 3
Drugs for Neglected Diseases 1
National Institute of Mental Health (NIMH) 1
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Sponsor Type

Sponsor Type for Sirturo
Sponsor Trials
Other 26
Industry 1
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Cipla
Federal Trade Commission
Cerilliant
Fish and Richardson
UBS
Medtronic
Mallinckrodt
Teva

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