Multi-drug Resistant TuberculosisPhase 3NCT01600963
A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis
A Phase 3 study testing Arm A Double-blind Phase: TMC207, Treatment Failure During Double-blind Phase: TMC207 and Treatment Failure During Follow-up Phase: TMC207 in people with Multi-drug Resistant Tuberculosis, run by Janssen Infectious Diseases BVBA at 44 sites in 17 countries.
Trial summary
The purpose of this study is to provide safety and efficacy data for TMC207 and to demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the BR plus placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi-drug Resistant Tuberculosis
- What is being tested?
- Arm A Double-blind Phase: TMC207, Treatment Failure During Double-blind Phase: TMC207 and Treatment Failure During Follow-up Phase: TMC207
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 44 sitesin 17 countries
- Study dates
- Mar 2014to Nov 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with sputum smear-positive pulmonary Mycobacterium multi-drug resistant tuberculosis; including pre-extensively drug resistant TB, and positive for acid fast bacilli on direct smear examination of expectorated or induced sputum specimen (>=1+ smear positive within the preceding 3 weeks) at screening and also on Day -1
Who cannot join
- Has known infection with extensively drug resistant tuberculosis isolate
- Has a clinically significant active medical condition such as, but not limited to, hepatic, pancreatic, renal, cardiovascular, gastrointestinal, hematologic, neurologic, locomotor, immunologic, ophthalmologic (e.g., corneal opacification or ulcers, uveitis, chorioretinitis), metabolic (except stable diabetes based on the investigator's judgement), endocrine, oncological disease, muscular disease (e.g., myositis, rhabdomyolysis), or psychiatric, dermatological illness, or any other illness that the investigator considers should exclude the patient or that could interfere with the interpretation of the study results. Eligibility of patients with poorly controlled diabetes as indicated by hemoglobin A1c higher than the normal range at screening should be based on the investigators judgment
Trial locations and contacts
44 sites in 17 countries.
44 sites in 17 countries
China7 sites
Study site
Beijing
Study site
Changsha
Study site
Chongqing
Study site
Fuzhou
Study site
Jinan
Study site
Nanjing
Study site
Shanghai
Russia6 sites
Study site
Arkhangelsk
Study site
Moscow
Study site
Novosibirsk
Study site
Oryol
Study site
Saint Petersburg
Study site
Yekaterinburg
South Korea6 sites
Study site
Busan
Study site
Daegu
Study site
Gwangju
Study site
Gyeongsangnam-Do
Study site
Incheon
Study site
Seoul
Taiwan4 sites
Study site
Changhua County
Study site
New Taipei City
Study site
Taichung
Study site
Tainan
Brazil3 sites
Study site
Porto Alegre
Study site
Rio de Janeiro
Study site
São Paulo
South Africa3 sites
Study site
Paarl
Study site
Sandringham
Study site
Ysterplaat
About this study
Official title: A Phase III Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Efficacy and Safety of TMC207 in Subjects With Sputum Smear-positive Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB)
The purpose of this study is to provide safety and efficacy data for TMC207 and to demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the BR plus placebo.
Read the detailed description
This is a randomized (individuals will be assigned by chance to study treatments), double-blind (individual and investigator will not know the identity of study treatments), placebo (substance containing no active medication)-controlled, 2-arm study in patients with sputum smear-positive pulmonary infection with multi-drug resistant tuberculosis (MDR-TB) defined as tuberculosis (TB) due to infection with a strain of Mycobacterium tuberculosis (M. tuberculosis) that is resistant to both isoniazid and rifampin, or pre-extensively drug resistant (pre-XDR-TB) defined as TB due to infection with an MDR strain of M. tuberculosis that is resistant either to at least one of the injectable second-line drugs [amikacin, kanamycin, or capreomycin] or to any fluoroquinolone, but not both). Approximately 600 patients with sputum smear-positive pulmonary infection with MDR-TB or pre-XDR TB will receive a background regimen (BR) of MDR-TB therapy and will be randomly assigned in a 1:1 ratio to one of 2 treatment arms (Arms A [TMC207 + BR] and B [placebo + BR]). All patients will receive TMC207 or placebo in combination with a BR of MDR-TB therapy. TMC207 (or matching placebo) will be taken as oral tablets at a once daily dose of 400 mg for the first 2 weeks and 200 mg 3 times/week for the remaining period of TMC207 (or matching placebo) administration. The study will consist of a screening phase of a maximum of 3 weeks, a 36-week double-blind treatment phase, followed by a 48-week follow-up phase up to Week 84, also referred to as the treatment-free follow-up. After the treatment-free follow-up phase, there will be a safety follow-up phase of 48 weeks up to Week 132. Patients from Arms A or B who fail treatment according to prespecified criteria will be given the option to receive 24 weeks of TMC207 plus an individualized salvage regimen taken for a duration consistent with national TB guidelines. Efficacy and pharmacokinetic evaluations will be performed at time points as detailed in the protocol. Safety will be monitored throughout the study.
- Conditions
- Multi-drug Resistant Tuberculosis
- Being tested
- Arm A Double-blind Phase: TMC207, Arm B Double-blind Phase: Placebo, Treatment Failure During Double-blind Phase: TMC207, Treatment Failure During Follow-up Phase: TMC207
- Keywords
- Multi-drug resistant tuberculosis, Pre-extensively drug resistant tuberculosis, TMC207, Background regimen
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm A Double-blind Phase: TMC207Drug
Type=exact number, unit=mg, number=400 mg for the first 2 weeks and 200 mg 3 times per week for the remainder of the treatment period, form=tablet, route=oral administration.
Arm B Double-blind Phase: PlaceboDrug
Form=tablet, route=oral administration, taken once daily for 2 weeks then 3 times per week for the remainder of the treatment period.
Treatment Failure During Double-blind Phase: TMC207Drug
Type=exact number, unit=mg, number=200 mg 3 times per week, form=tablet, route=oral administration.
Treatment Failure During Follow-up Phase: TMC207Drug
Type=exact number, unit=mg, number=400 mg once daily for 2 wks and 200mg three times per week for 22 weeks, form=tablet, route=oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Arm A Double-blind Phase: TMC207; Drug: Treatment Failure During Double-blind Phase: TMC207; Drug: Treatment Failure During Follow-up Phase: TMC207 |
| Arm B | Placebo comparator | Not described Receives: Drug: Arm B Double-blind Phase: Placebo; Drug: Treatment Failure During Double-blind Phase: TMC207; Drug: Treatment Failure During Follow-up Phase: TMC207 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with favorable treatment outcome at Week 60
Measured: Week 60
Secondary outcomes (27)
Number of patients with confirmed culture conversion at Week 84
Measured: Week 84
Number of patients with confirmed culture conversion at Week 60 or at time of trial discontinuation
Measured: Up to Week 132
The number of patients with development of pre-extensively drug-resistant tuberculosis and extensively drug-resistant tuberculosis
Measured: Up to Week 132
Time to sputum culture conversion
Measured: Up to Week 132
Number of patients with negative culture and smear for tuberculosis
Measured: Up to Week 132
Time to positive signal in Mycobacteria Growth Indicator Tube (MGIT960)
Measured: Up to Week 132
Number of patients with confirmed culture conversion by lung cavity status
Measured: Up to Week 132
Number of patients with confirmed culture conversion by geographic region
Measured: Up to Week 132
Number of patients with confirmed culture conversion by human immunodeficiency virus status
Measured: Up to Week 132
Number of patients with confirmed culture conversion by baseline resistance to anti-tuberculosis therapy
Measured: Up to Week 132
Number of patients with Tuberculosis Symptom Profile symptoms at Week 36 and at the end of the treatment-free follow up
Measured: Up to Week 132
Number of tuberculosis-related deaths per investigator assessment
Measured: Up to Week 132
Number of patients with weight gain (greater than 5 percent) at Week 36 and at the end of the treatment-free follow up
Measured: Up to Week 132
Number of patients with improvements in laboratory assessments at Week 36 and at the end of the treatment-free follow up
Measured: Up to Week 132
Number of patients with improvements in chest radiograph assessments at Week 36 and at the end of the treatment-free follow up
Measured: Up to Week 132
Number of patients that received salvage regimen with favorable treatment outcome 24 weeks after the end of the individualized salvage regimen
Measured: Up to Week 132
Mean plasma concentrations of TMC207
Measured: Up to Week 36
Mean plasma concentrations of N-monodesmethyl metabolite of TMC207
Measured: Up to Week 36
Number of patients affected by an adverse event
Measured: Up to Week 132
Number of patients with confirmed culture conversion at Week 36
Measured: Up to Week 132
Number of patients who required lung surgeries (resection or pneumonectomy) during the study
Measured: Week 84
Number of patients with confirmed culture conversion by baseline albumin grade
Measured: Up to Week 132
Number of patients with confirmed culture conversion by baseline TMC207 minimal inhibitory concentration
Minimal inhibitory concentration is defined as lowest concentration of an antimicrobial agent that will inhibit the visible growth of an organism.
Measured: Up to Week 132
Number of patients with confirmed culture conversion at Week 132
Measured: Week 132
Number of patients who required lung surgeries (resection or pneumonectomy) during the study
Measured: Week 132
Number of patients who experienced death
Measured: Up to Week 132
Number of patients will be qualified as cure based on the WHO outcome definition and the number of treatment failures, deaths, transfer out/defaults, and treatment completed
Cure is defined as an multidrug-resistant tuberculosis (MDR-TB) patient who has completed the study procedures according to the protocol and has at least five consecutive negative cultures from samples collected at least 30 days apart in the final 12 months of the study. If only one positive culture is reported during that time, a patient may still be considered cured, provided that this positive culture is followed by a minimum of 3 consecutive negative cultures taken at least 30 days apart. Treatment failure is defined as a patient who completed the study procedures and was not cured as per the "Cure" definition based on the WHO classification during the study procedures. Defaults is defined as patients who discontinued study procedures for any reason. Treatment completed is defined as an MDR-TB patient who has completed the study procedures but does not meet the definition for cure or treatment failure due to lack of bacteriologic results.
Measured: Up to Week 132
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMar 2014
- Primary completionJul 2016 (estimated)
- Study completionNov 2022 (estimated)
Why it stopped: PhIII program revised; TMC207-C210 cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-drug Resistant TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Infectious Diseases BVBA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Infectious Diseases BVBA Clinical Trial, Study director, Janssen Infectious Diseases BVBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600963
- Sponsor's protocol ID
- CR100807
- Other IDs
- TMC207-TIDP13-C210, 2011-000653-23, U1111-1135-7013
- Status last verified
- Nov 2015
- First submitted
- 24 Apr 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Efficacy and Safety of TMC207 in Subjects With Sputum Smear-positive Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB)
- ClinicalTrials.gov ID
- NCT01600963
- Acronym / sponsor ID
- CR100807
- Conditions
- Multi-drug Resistant Tuberculosis
- Keywords
- Multi-drug resistant tuberculosis, Pre-extensively drug resistant tuberculosis, TMC207, Background regimen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PhIII program revised; TMC207-C210 cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen Infectious Diseases BVBAIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 17 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide safety and efficacy data for TMC207 and to demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the BR plus placebo.
Detailed description
This is a randomized (individuals will be assigned by chance to study treatments), double-blind (individual and investigator will not know the identity of study treatments), placebo (substance containing no active medication)-controlled, 2-arm study in patients with sputum smear-positive pulmonary infection with multi-drug resistant tuberculosis (MDR-TB) defined as tuberculosis (TB) due to infection with a strain of Mycobacterium tuberculosis (M. tuberculosis) that is resistant to both isoniazid and rifampin, or pre-extensively drug resistant (pre-XDR-TB) defined as TB due to infection with an MDR strain of M. tuberculosis that is resistant either to at least one of the injectable second-line drugs [amikacin, kanamycin, or capreomycin] or to any fluoroquinolone, but not both). Approximately 600 patients with sputum smear-positive pulmonary infection with MDR-TB or pre-XDR TB will receive a background regimen (BR) of MDR-TB therapy and will be randomly assigned in a 1:1 ratio to one of 2 treatment arms (Arms A [TMC207 + BR] and B [placebo + BR]). All patients will receive TMC207 or placebo in combination with a BR of MDR-TB therapy. TMC207 (or matching placebo) will be taken as oral tablets at a once daily dose of 400 mg for the first 2 weeks and 200 mg 3 times/week for the remaining period of TMC207 (or matching placebo) administration. The study will consist of a screening phase of a maximum of 3 weeks, a 36-week double-blind treatment phase, followed by a 48-week follow-up phase up to Week 84, also referred to as the treatment-free follow-up. After the treatment-free follow-up phase, there will be a safety follow-up phase of 48 weeks up to Week 132. Patients from Arms A or B who fail treatment according to prespecified criteria will be given the option to receive 24 weeks of TMC207 plus an individualized salvage regimen taken for a duration consistent with national TB guidelines. Efficacy and pharmacokinetic evaluations will be performed at time points as detailed in the protocol. Safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Arm A Double-blind Phase: TMC207, Drug: Treatment Failure During Double-blind Phase: TMC207, Drug: Treatment Failure During Follow-up Phase: TMC207 |
| Arm B | Placebo comparator | Drug: Arm B Double-blind Phase: Placebo, Drug: Treatment Failure During Double-blind Phase: TMC207, Drug: Treatment Failure During Follow-up Phase: TMC207 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with sputum smear-positive pulmonary Mycobacterium multi-drug resistant tuberculosis; including pre-extensively drug resistant TB, and positive for acid fast bacilli on direct smear examination of expectorated or induced sputum specimen (>=1+ smear positive within the preceding 3 weeks) at screening and also on Day -1
Key exclusion criteria (2 listed)
- Has known infection with extensively drug resistant tuberculosis isolate
- Has a clinically significant active medical condition such as, but not limited to, hepatic, pancreatic, renal, cardiovascular, gastrointestinal, hematologic, neurologic, locomotor, immunologic, ophthalmologic (e.g., corneal opacification or ulcers, uveitis, chorioretinitis), metabolic (except stable diabetes based on the investigator's judgement), endocrine, oncological disease, muscular disease (e.g., myositis, rhabdomyolysis), or psychiatric, dermatological illness, or any other illness that the investigator considers should exclude the patient or that could interfere with the interpretation of the study results. Eligibility of patients with poorly controlled diabetes as indicated by hemoglobin A1c higher than the normal range at screening should be based on the investigators judgment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm A Double-blind Phase: TMC207Type=exact number, unit=mg, number=400 mg for the first 2 weeks and 200 mg 3 times per week for the remainder of the treatment period, form=tablet, route=oral administration. | Drug | Arm A |
| Arm B Double-blind Phase: PlaceboForm=tablet, route=oral administration, taken once daily for 2 weeks then 3 times per week for the remainder of the treatment period. | Drug | Arm B |
| Treatment Failure During Double-blind Phase: TMC207Type=exact number, unit=mg, number=200 mg 3 times per week, form=tablet, route=oral administration. | Drug | Arm A, Arm B |
| Treatment Failure During Follow-up Phase: TMC207Type=exact number, unit=mg, number=400 mg once daily for 2 wks and 200mg three times per week for 22 weeks, form=tablet, route=oral administration. | Drug | Arm A, Arm B |
Primary outcome
Number of patients with favorable treatment outcome at Week 60
Time frame: Week 60
27 secondary outcomes
Number of patients with confirmed culture conversion at Week 84
Time frame: Week 84
Number of patients with confirmed culture conversion at Week 60 or at time of trial discontinuation
Time frame: Up to Week 132
The number of patients with development of pre-extensively drug-resistant tuberculosis and extensively drug-resistant tuberculosis
Time frame: Up to Week 132
Time to sputum culture conversion
Time frame: Up to Week 132
Number of patients with negative culture and smear for tuberculosis
Time frame: Up to Week 132
Time to positive signal in Mycobacteria Growth Indicator Tube (MGIT960)
Time frame: Up to Week 132
Number of patients with confirmed culture conversion by lung cavity status
Time frame: Up to Week 132
Number of patients with confirmed culture conversion by geographic region
Time frame: Up to Week 132
Number of patients with confirmed culture conversion by human immunodeficiency virus status
Time frame: Up to Week 132
Number of patients with confirmed culture conversion by baseline resistance to anti-tuberculosis therapy
Time frame: Up to Week 132
Number of patients with Tuberculosis Symptom Profile symptoms at Week 36 and at the end of the treatment-free follow up
Time frame: Up to Week 132
Number of tuberculosis-related deaths per investigator assessment
Time frame: Up to Week 132
Number of patients with weight gain (greater than 5 percent) at Week 36 and at the end of the treatment-free follow up
Time frame: Up to Week 132
Number of patients with improvements in laboratory assessments at Week 36 and at the end of the treatment-free follow up
Time frame: Up to Week 132
Number of patients with improvements in chest radiograph assessments at Week 36 and at the end of the treatment-free follow up
Time frame: Up to Week 132
Number of patients that received salvage regimen with favorable treatment outcome 24 weeks after the end of the individualized salvage regimen
Time frame: Up to Week 132
Mean plasma concentrations of TMC207
Time frame: Up to Week 36
Mean plasma concentrations of N-monodesmethyl metabolite of TMC207
Time frame: Up to Week 36
Number of patients affected by an adverse event
Time frame: Up to Week 132
Number of patients with confirmed culture conversion at Week 36
Time frame: Up to Week 132
Number of patients who required lung surgeries (resection or pneumonectomy) during the study
Time frame: Week 84
Number of patients with confirmed culture conversion by baseline albumin grade
Time frame: Up to Week 132
Number of patients with confirmed culture conversion by baseline TMC207 minimal inhibitory concentration
Time frame: Up to Week 132
Number of patients with confirmed culture conversion at Week 132
Time frame: Week 132
Number of patients who required lung surgeries (resection or pneumonectomy) during the study
Time frame: Week 132
Number of patients who experienced death
Time frame: Up to Week 132
Number of patients will be qualified as cure based on the WHO outcome definition and the number of treatment failures, deaths, transfer out/defaults, and treatment completed
Time frame: Up to Week 132
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Infectious Diseases BVBA Clinical Trial study director
Janssen Infectious Diseases BVBA
44 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arm A Double-blind Phase: TMC207, Treatment Failure During Double-blind Phase: TMC207 and Treatment Failure During Follow-up Phase: TMC207 in people with Multi-drug Resistant Tuberculosis, run by Janssen Infectious Diseases BVBA at 44 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in China, Russia, South Korea, Taiwan, Brazil and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with favorable treatment outcome at Week 60 (time frame: Week 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.