A Study to Evaluate the Efficacy and Safety of Bedaquiline (TMC207) in Participants With Multibacillary Leprosy
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|ClinicalTrials.gov Identifier: NCT03384641|
Recruitment Status : Active, not recruiting
First Posted : December 27, 2017
Last Update Posted : August 3, 2022
|Condition or disease||Intervention/treatment||Phase|
|Leprosy, Multibacillary||Drug: Bedaquiline 200 mg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study to Evaluate the Efficacy and Safety of TMC207 in Subjects With Multibacillary Leprosy|
|Actual Study Start Date :||September 26, 2018|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||February 23, 2024|
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.
Other Name: TMC207
- Change from Baseline in the Odds of Mycobacterium leprae (M. leprae) Growth in Mouse Footpads Following 8 Weeks of Treatment with Bedaquiline [ Time Frame: Baseline up to Week 8 ]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.
- Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 124 Weeks ]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.
- Number of Participants with AEs by Severity [ Time Frame: Up to 124 Weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384641
|Instituto Lauro de Souza Lima|
|Bauru, Brazil, 17034-971|
|Alfredo da Matta Foundation|
|Manaus, Brazil, 69065-130|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|