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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Infectious Diseases BVBA
ClinicalTrials.gov Identifier:
NCT00910871
First received: May 28, 2009
Last updated: April 3, 2013
Last verified: April 2013
Results First Received: January 30, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tuberculosis
Interventions: Drug: TMC207
Drug: Background Regimen (BR) for MDR-TB

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This trial is ongoing at 33 centers in Asia, South Africa, Eastern Europe, and South America. The interim analysis is reported from 19-Aug-2009 (date first informed consent signed) to 29-Mar-2011 (cut-off date when all participants completed 24 weeks of treatment with TMC207 or discontinued earlier).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 241 participants were enrolled in the study; 8 participants were withdrawn from the study before study drug administration and 233 started treatment with study drug. As of the data cut-off date for the interim analysis, 203 participants completed 24 weeks of treatment and continued participation in the study.

Reporting Groups
  Description
TMC207 / Background Regimen Weeks 1 and 2: 400 mg TMC207 once daily and Background Regimen (BR) for the treatment of Tuberculosis. Week 3 to 24: 200 mg TMC207 three times a week and BR. Week 25 to end of study: BR per national treatment guidelines.

Participant Flow:   Overall Study
    TMC207 / Background Regimen  
STARTED     233  
Ongoing at Time of Data Cut-off Date     203  
COMPLETED     0  
NOT COMPLETED     233  
Adverse Event                 3  
Death                 5  
Lost to Follow-up                 2  
Protocol Violation                 5  
Withdrawal by Subject                 8  
Inclusion/exclusion criteria not met                 5  
Reason not specified                 2  
Patients continuing in the study                 203  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
TMC207 / Background Regimen Weeks 1 and 2: 400 mg TMC207 once daily and Background Regimen (BR) for the treatment of Tuberculosis. Week 3 to 24: 200 mg TMC207 three times a week and BR. Week 25 to end of study: BR per national treatment guidelines.

Baseline Measures
    TMC207 / Background Regimen  
Number of Participants  
[units: participants]
  233  
Age  
[units: years]
Mean ± Standard Deviation
  34.6  ± 12.09  
Gender  
[units: participants]
 
Female     83  
Male     150  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Median Time to Sputum Culture Conversion   [ Time Frame: Week 24 ]

2.  Secondary:   The Percentage of Participants With Sputum Culture Conversion   [ Time Frame: Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
In Participant Flow, the 5 deaths shown are restricted to those that occurred during the trial (up to database-cutoff) and does not include deaths reported after discontinuation in long-term survival follow-up.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Leader
Organization: Janssen Infectious Diseases – Diagnostics BVBA
phone: 1 609 730-7768


No publications provided


Responsible Party: Janssen Infectious Diseases BVBA
ClinicalTrials.gov Identifier: NCT00910871     History of Changes
Obsolete Identifiers: NCT00980811
Other Study ID Numbers: CR012352, TMC207-TiDP13-C209, 2008-008444-25
Study First Received: May 28, 2009
Results First Received: January 30, 2013
Last Updated: April 3, 2013
Health Authority: United States: Food and Drug Administration
USA: FOOD AND DRUG ADMINISTRATION - CENTER FOR DRUG EVALUATION AND RESEARCH
Republic of Korea: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health