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| ID | Type | Description | Link |
|---|---|---|---|
| TMC207LEP2001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the efficacy of an 8-week bedaquiline monotherapy regimen in participants with treatment-naive, multibacillary (MB) leprosy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bedaquiline | Experimental | Participants will receive bedaquiline 200 (milligram) mg (2*100 mg tablets) once daily for 2 weeks followed by 100 mg tablet three times a week (tiw) for 6 weeks with at least 48 hours between doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bedaquiline 200 mg | Drug | Participants will receive bedaquiline 200 mg (2*100 mg tablets) once daily for 2 weeks followed by 100 mg tablet tiw for 6 weeks with at least 48 hours between doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Odds of Mycobacterium leprae (M. leprae) Growth in Mouse Footpads Following 8 Weeks of Treatment with Bedaquiline | Change from baseline in the odds of M. leprae growth in mouse footpads will be evaluated. M. leprae bacilli will be inoculated in footpads of mice, according to the method of Shepard. M. leprae growth will be determined by technologists trained and experienced in mouse footpad procedures, at 1 year after infection (or at mouse death or humane endpoint, if it occurs greater than or equal to [>=] 6 months after footpad inoculation). The number of footpads with positive growth (>=10^5 M. leprae) will be counted and used to determine the odds of bacterial growth. | Baseline up to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to 124 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Lauro de Souza Lima | Bauru | 17034-971 | Brazil | |||
| Fundacao Hospitalar de Dermatologia Tropical e Venereologia Alfredo da Matta - FUHAM |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39665652 | Derived | Barreto J, Sammarco Rosa P, Adams L, Aguilar Z, Bakare N, Chaplan SR, Akli RD, Ernault E, Kulke S, Lounis N, Millington D, Palmer JA, Remmerie B, Wang M, Young S, Truman R, Rebello PFB. Bedaquiline Monotherapy for Multibacillary Leprosy. N Engl J Med. 2024 Dec 12;391(23):2212-2218. doi: 10.1056/NEJMoa2312928. |
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| ID | Term |
|---|---|
| D056006 | Leprosy, Multibacillary |
| ID | Term |
|---|---|
| D007918 | Leprosy |
| D009165 | Mycobacterium Infections, Nontuberculous |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
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| ID | Term |
|---|---|
| C493870 | bedaquiline |
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| Number of Participants with AEs by Severity |
Severity of adverse events will be graded by using division of microbiology and infectious diseases (DMID) adult toxicity scale to estimate grade of severity. Severity scale ranges from Grade 1 (Mild) to Grade 4 (Life-threatening). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, and Grade 4= Life-threatening. |
| Up to 124 Weeks |
| Manaus |
| 69065-130 |
| Brazil |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |