To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary 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.
3 other identifiers
interventional
241
12 countries
27
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2009
Typical duration for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2009
CompletedFirst Posted
Study publicly available on registry
June 1, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
May 16, 2013
CompletedApril 24, 2015
April 1, 2015
1.5 years
May 28, 2009
January 30, 2013
April 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Median Time to Sputum Culture Conversion
The table below shows the median time in days to culture conversion for the modified intent-to-treat (mITT) population up to Week 24. Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multi-drug resistant tuberculosis (MDR-TB) taken at least 25 days apart. Participants who discontinued during the 24-week period were considered non-responders (based on Mycobacteria Growth Indicator Tube \[MGIT\]).
Up to Week 24
Secondary Outcomes (1)
The Percentage of Participants With Sputum Culture Conversion
Week 120
Study Arms (1)
TMC207
EXPERIMENTALTMC207 400mg once daily for 2 weeks then 200mg three times a week for 22 weeks in addition to Background Regimen (BR) for the treatment of multi-drug resistant tuberculosis (MDR-TB).
Interventions
Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as specified in the protocol for up to 96 weeks.
Eligibility Criteria
You may qualify if:
- Females of child-bearing potential must be using and are willing to continue using effective birth control methods, or be willing to practice sexual abstinence throughout treatment or be nonheterosexual active
- Confirmed pulmonary MDR-TB infection including those infected with XDR (extensively drug resistant)-TB
- Positive for acid-fast bacilli (AFB) on direct smear examination of expectorated sputum specimen (= 1+ smear-positive)
- HIV-positive patients are eligible, provided they meet the requirements as described in the protocol
- Must voluntarily sign the Informed Consent Form (ICF) prior to starting any study activities
- Willing to comply with protocol requirements
- Willing to comply with NTP treatment guidelines
You may not qualify if:
- Patients having a known or suspected hypersensitivity or serious adverse reaction to TMC207
- Patients with significant cardiac arrhythmia requiring medication
- Patients with complicated or severe extrapulmonary manifestations of TB, including central nervous system infection
- Patients with certain QT/QTc interval characteristics as described in the protocol
- Patients having participated in other clinical studies with investigational agents, within 8 weeks prior to trial start
- Women who are pregnant or breastfeeding
- Patients who have previously received treatment with TMC207 as part of a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Unknown Facility
Beijing, China
Unknown Facility
Fuzhou, China
Unknown Facility
Jinan, China
Unknown Facility
Nanjing, China
Unknown Facility
Shanghai, China
Unknown Facility
Talinn, Estonia
Unknown Facility
Tartu, Estonia
Unknown Facility
Nairobi, Kenya
Unknown Facility
Stopinu Region, Latvia
Unknown Facility
Callao, Peru
Unknown Facility
Lima, Peru
Unknown Facility
Quezon City, Philippines
Unknown Facility
Arkhangelsk, Russia
Unknown Facility
Moscow, Russia
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Oryol, Russia
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Bellville West Cape, South Africa
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Durban, South Africa
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Sandringham, South Africa
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Seoul, South Korea
Unknown Facility
Suwon, South Korea
Unknown Facility
Nakhon, Thailand
Unknown Facility
Nonthaburi, Thailand
Unknown Facility
Istanbul, Turkey (Türkiye)
Unknown Facility
Keçiören, Turkey (Türkiye)
Unknown Facility
Donetsk, Ukraine
Unknown Facility
Kiev, Ukraine
Unknown Facility
Odesa, Ukraine
Related Publications (2)
Bolhuis MS, Akkerman OW, Sturkenboom MGG, van Boven JFM, Alffenaar JC, Stevens J. Bedaquiline exposure in people with drug-resistant TB treated for diabetes: analysis of two phase 2 trials. Int J Tuberc Lung Dis. 2023 Apr 1;27(4):335-337. doi: 10.5588/ijtld.22.0581. No abstract available.
PMID: 37035978DERIVEDPym AS, Diacon AH, Tang SJ, Conradie F, Danilovits M, Chuchottaworn C, Vasilyeva I, Andries K, Bakare N, De Marez T, Haxaire-Theeuwes M, Lounis N, Meyvisch P, Van Baelen B, van Heeswijk RP, Dannemann B; TMC207-C209 Study Group. Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis. Eur Respir J. 2016 Feb;47(2):564-74. doi: 10.1183/13993003.00724-2015. Epub 2015 Dec 2.
PMID: 26647431DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
In Participant Flow, the 12 deaths shown are restricted to those that occurred during the trial and do not include 4 deaths reported after discontinuation in long-term survival follow-up.
Results Point of Contact
- Title
- Medical Leader
- Organization
- Janssen Infectious Diseases - Diagnostics BVBA
Study Officials
- STUDY DIRECTOR
Janssen Infectious Diseases BVBA Clinical Trial
Janssen Infectious Diseases BVBA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2009
First Posted
June 1, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2011
Study Completion
January 1, 2013
Last Updated
April 24, 2015
Results First Posted
May 16, 2013
Record last verified: 2015-04