Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00910871 | 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. | PHASE2 | COMPLETED | 241 | — | — | Sep 1, 2009 | Jan 1, 2013 | Apr 24, 2015 | 27 | China, Estonia +10 |
| NCT00449644 | TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB). | PHASE2 | COMPLETED | 208 | — | — | Jun 1, 2007 | Oct 1, 2012 | Apr 29, 2014 | 16 | Brazil, India +6 |
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 \[MGIT\]).
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.
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.
| Arm | Type | Description |
|---|---|---|
| TMC207 | EXPERIMENTAL | TMC207 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). |
| TMC207 Stage 1 | EXPERIMENTAL | TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 6 weeks in addition to Background Regimen (BR) for multi-drug resistant tuberculosis (MDR-TB). |
| Placebo Stage 1 | PLACEBO_COMPARATOR | Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 weeks in addition to BR for MDR-TB. |
| TMC207 Stage 2 | EXPERIMENTAL | TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 22 weeks in addition to BR for MDR-TB. |
| Placebo Stage 2 | PLACEBO_COMPARATOR | Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 22 weeks in addition to BR for MDR-TB. |
| Name | Type | Description |
|---|---|---|
| TMC207 | DRUG | TMC207 400mg once daily for 2 weeks then 200mg three times a week for 22 weeks. |
| Background Regimen (BR) for MDR-TB | DRUG | 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. |
| Placebo | DRUG | Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 or 22 weeks. |
| Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis) | DRUG | Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as speciified in the protocol for up to 96 weeks. |
Inclusion Criteria: * 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 wit...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Viatris, Inc. | VTRS | 1 | PHASE3 | Bedaquiline |
| Johnson & Johnson | JNJ | 1 | PHASE2 | Bedaquiline, Background Regimen |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT164a1, BNT164b1 |
| Harvard Bioscience, Inc. | HBIO | 1 | — | Bdq, Lzd, Lfx, Dlm, Cfz |