Trials / Completed
CompletedNCT03384641
A Study to Evaluate the Efficacy and Safety of Bedaquiline (TMC207) in Participants With Multibacillary Leprosy
An Open-Label Study to Evaluate the Efficacy and Safety of TMC207 in Subjects With Multibacillary Leprosy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-09-26
- Primary completion
- 2023-01-13
- Completion
- 2024-01-09
- First posted
- 2017-12-27
- Last updated
- 2024-02-02
Locations
2 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03384641. Inclusion in this directory is not an endorsement.