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Telacebec (T) Treatment in Adults With Buruli Ulcer (BU).
Sponsor: Barwon Health
Summary
The goal of this interventional clinical trial is to determine if treatment with 2-4 weeks of telacebac (T) will completely heal lesions in participants with Buruli ulcer (BU) by 52 weeks after treatment initiation, without relapse and/or surgery. Males and females age 18 and older will be included. • Participants will attend visits every 2 weeks during treatment and thereafter every 2 weeks until week 24 Thereafter they will be followed by visits at weeks 30, 40, and 52. From week 10 to week 52, if the lesion has healed, follow-up visits may be remote.
Official title: A Phase 2 Multicentre, Open-label Study to Evaluate the Efficacy, Safety and Tolerability, and Pharmacokinetics of 14 -28 Days Telacebec Treatment in Adult Participants With Buruli Ulcer.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2024-07-09
Completion Date
2026-12
Last Updated
2025-12-10
Healthy Volunteers
No
Conditions
Interventions
Telacebec
The test product will be supplied as Telacebec 100mg tablets.
Locations (2)
Barwon Health
Geelong, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Australia