Trial · NCT00449644
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
NCT00449644, Phase 2, Completed, Janssen Infectious Diseases BVBA; results first posted 2013-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB). Trials, record NCT00449644. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00449644
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
- NCT number
- NCT00449644
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 208 participants, actual
- Lead sponsor
- Janssen Infectious Diseases BVBA
- Conditions
- Tuberculosis
- Interventions
- TMC207, Placebo, Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
- First posted
- 2007-03-20
- Last updated
- 2014-04-29
- Other registries' IDs
- eudract:2007-004462-40
- Results first posted
- 2013-06-25
- Limitations and caveats
In Participant Flow, deaths occurring during the trial are reported. In addition, 1 TMC207 and 2 placebo subjects in stage 1 and 4 TMC207 and 1 placebo subject in stage 2 died after discontinuation during long-term survival follow-up.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Time to Sputum Culture Conversion at Week 8 (Stage 1) | Week 8, Stage 1 | The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment. |
| Primary | The Time to Sputum Culture Conversion at Week 24 (Stage 2) | Week 24, Stage 2 | The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment. |
| Secondary | The Time to Sputum Culture Conversion at Week 24 (Stage 1) | Week 24, Stage 1 | The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment. |
| Secondary | The Time to Sputum Culture Conversion at Week 72 (Stage 2) | Week 72, Stage 2 | The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment. |
| Secondary | The Percentage of Participants With Sputum Culture Conversion (Stage 1) | Week 8, 24, and 104 (Stage 1) | The table below shows the percentage of participants in Stage 1 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders. |
| Secondary | The Percentage of Participants With Sputum Culture Conversion (Stage 2) | Week 24, Week 72, and Week 120 (Stage 2) | The table below shows the percentage of participants in Stage 2 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Time to Sputum Culture Conversion at Week 8 (Stage 1) | Week 8, Stage 1 | The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy. | Days | MEDIAN |
| PRIMARY | The Time to Sputum Culture Conversion at Week 24 (Stage 2) | Week 24, Stage 2 | The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy. | Days | MEDIAN |
| SECONDARY | The Time to Sputum Culture Conversion at Week 24 (Stage 1) | Week 24, Stage 1 | The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy. | Days | MEDIAN |
| SECONDARY | The Time to Sputum Culture Conversion at Week 72 (Stage 2) | Week 72, Stage 2 | The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy. | Days | MEDIAN |
| SECONDARY | The Percentage of Participants With Sputum Culture Conversion (Stage 1) | Week 8, 24, and 104 (Stage 1) | The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy. | Percentage of Participants | NUMBER |
| SECONDARY | The Percentage of Participants With Sputum Culture Conversion (Stage 2) | Week 24, Week 72, and Week 120 (Stage 2) | The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Time to Sputum Culture Conversion at Week 8 (Stage 1) | TMC207 / BR (Stage 1) | 51 | 95% Confidence Interval 30 to NA | Days | |
| The Time to Sputum Culture Conversion at Week 8 (Stage 1) | Placebo / BR (Stage 1) | NA | 95% Confidence Interval NA to NA | Days | |
| The Time to Sputum Culture Conversion at Week 24 (Stage 2) | TMC207 / BR (Stage 2) | 83 | 95% Confidence Interval 56 to 97 | Days | |
| The Time to Sputum Culture Conversion at Week 24 (Stage 2) | Placebo / BR (Stage 2) | 125 | 95% Confidence Interval 98 to 168 | Days | |
| The Time to Sputum Culture Conversion at Week 24 (Stage 1) | TMC207 / BR (Stage 1) | 70 | 95% Confidence Interval 49 to 100 | Days | |
| The Time to Sputum Culture Conversion at Week 24 (Stage 1) | Placebo / BR (Stage 1) | 126 | 95% Confidence Interval 98 to 134 | Days | |
| The Time to Sputum Culture Conversion at Week 72 (Stage 2) | TMC207 / BR (Stage 2) | 86 | 95% Confidence Interval 70 to 99 | Days | |
| The Time to Sputum Culture Conversion at Week 72 (Stage 2) | Placebo / BR (Stage 2) | 168 | 95% Confidence Interval 112 to 345 | Days | |
| The Percentage of Participants With Sputum Culture Conversion (Stage 1) | TMC207 / BR (Stage 1) | Week 8 | 47.6 | Percentage of Participants | |
| The Percentage of Participants With Sputum Culture Conversion (Stage 1) | Placebo / BR (Stage 1) | Week 8 | 8.7 | Percentage of Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TMC207 / BR (Stage 1) | 23 | |
| Overall Study | STARTED | Placebo / BR (Stage 1) | 24 | |
| Overall Study | STARTED | TMC207 / BR (Stage 2) | 79 | |
| Overall Study | STARTED | Placebo / BR (Stage 2) | 81 | |
| Overall Study | Rollover | TMC207 / BR (Stage 1) | 0 | |
| Overall Study | Rollover | Placebo / BR (Stage 1) | 0 | |
| Overall Study | Rollover | TMC207 / BR (Stage 2) | 0 | |
| Overall Study | Rollover | Placebo / BR (Stage 2) | 1 | |
| Overall Study | COMPLETED | TMC207 / BR (Stage 1) | 13 | |
| Overall Study | COMPLETED | Placebo / BR (Stage 1) | 11 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events316
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | TMC207 / BR (Stage 1) | 0 | 23 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo / BR (Stage 1) | 0 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | TMC207 / BR (Stage 2) | 6 | 79 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo / BR (Stage 2) | 3 | 81 | |
| other | Deafness | Ear and labyrinth disorders | TMC207 / BR (Stage 1) | 1 | 23 | |
| other | Deafness | Ear and labyrinth disorders | Placebo / BR (Stage 1) | 1 | 24 | |
| other | Deafness | Ear and labyrinth disorders | TMC207 / BR (Stage 2) | 5 | 79 | |
| other | Deafness | Ear and labyrinth disorders | Placebo / BR (Stage 2) | 4 | 81 | |
| other | Deafness bilateral | Ear and labyrinth disorders | TMC207 / BR (Stage 1) | 3 | 23 | |
| other | Deafness bilateral | Ear and labyrinth disorders | Placebo / BR (Stage 1) | 3 | 24 |
1 to 10 of 316Source ClinicalTrials.gov
See all 316 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TMC207 / BR (Stage 1) | ||
| Total, all-cause mortality | Placebo / BR (Stage 1) | ||
| Total, all-cause mortality | TMC207 / BR (Stage 2) | ||
| Total, all-cause mortality | Placebo / BR (Stage 2) | ||
| Total, other adverse events | TMC207 / BR (Stage 1) | 21 | 23 |
| Total, other adverse events | Placebo / BR (Stage 1) | 23 | 24 |
| Total, other adverse events | TMC207 / BR (Stage 2) | 75 | 79 |
| Total, other adverse events | Placebo / BR (Stage 2) | 75 | 81 |
| Total, serious adverse events | TMC207 / BR (Stage 1) | 1 | 23 |
| Total, serious adverse events | Placebo / BR (Stage 1) | 1 | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00449644
GET https://conductscience.org/api/trials/v1/NCT00449644/events?page=2