Telacebec (T) Treatment in Adults With Buruli Ulcer (BU). (TREAT BU)
Recruiting
Phase 2
Interventional Study
Buruli Ulcer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- Barwon Health · Government
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About This Trial
The goal of this interventional clinical trial is to demonstrate the complete BU lesion healing rate by 52 weeks after treatment initiation, without relapse and/or curative intent excision surgery, after 10-28 days of telacebec (T) treatment. 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 wee…
Trial Locations
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Eligibility Criteria
Major Inclusion Criteria:
* Clinical diagnosis of BU WHO categories, single or multiples:
Category I- a single lesion \< 5 cm Category II - a single lesion with cross-sectional diameter ≤ 10 cm Category III - where multiple and all lesions are ≤ 10 cm cross-sectional diameter
* Positive PCR or cu…
Contacts