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 8, 2015
Last verified: April 2015
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
A Phase II open label trial with TMC207 as part of multi-drug resistant mycobacterium tuberculosis (MDR-TB) treatment regimen in participants with sputum smear-positive pulmonary infection with MDR-TB.

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A total of 241 participants were enrolled in the study; 8 participants were withdrawn from the study before study drug administration and 233 started treatment with study drug.

Reporting Groups
  Description
TMC207 Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).

Participant Flow:   Overall Study
    TMC207  
STARTED     233  
COMPLETED     179  
NOT COMPLETED     54  
Adverse Event                 5  
Death                 12  
Lost to Follow-up                 8  
Protocol Violation                 11  
Withdrawal by Subject                 12  
Subject didn’t meet eligibility criteria                 5  
Undefined                 1  



  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.
Intent-to-treat (ITT) population included all participants who had at least 1 dose of TMC207, regardless of their compliance with the protocol.

Reporting Groups
  Description
TMC207 Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).

Baseline Measures
    TMC207  
Number of Participants  
[units: participants]
  233  
Age  
[units: years]
Mean ± Standard Deviation
  34.6  ± 12.1  
Gender  
[units: participants]
 
Female     83  
Male     150  



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

2.  Secondary:   The Percentage of Participants With Sputum Culture Conversion   [ Time Frame: Week 120 ]


  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 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.


  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 8, 2015
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