A Phase 2 interventional study of Bedaquiline 200 mg in Leprosy, Multibacillary, sponsored by Janssen Research & Development, LLC. Completed at 2 sites in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-02.
Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Drug: Bedaquiline 200 mg
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.
Also known as: TMC207
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.
Time frame: Baseline up to Week 8
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.
Time frame: Up to 124 Weeks
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.
Time frame: Up to 124 Weeks
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC