Telacebec (T) Treatment in Adults With Buruli Ulcer (BU).
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.
Barwon Health
140 participants
Jul 9, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Clinical diagnosis of BU
- Positive PCR or culture for confirmation of presence of mycobacterium ulcerans (MU).
Exclusion Criteria5
- Participants with the following known or suspected medical conditions:
- Any non BU related condition where participation in the study, as judged by the Investigator, could compromise the well-being of the participant or prevent, limit or confound protocol specified treatment and assessments.
- History or current ascites, jaundice, myasthenia gravis, clinically significant renal dysfunction \[estimated glomerular filtration rate (eGFR) < 30 mls/min\],
- History of previous BU in the previous 12 months (except current infection)
- Planned/expected to require curative intent excision surgery, defined as excision of lesion which may include surrounding macroscopically healthy tissue with the aim of helping to sterilize the wound rather than improve wound healing alone, for their BU during the entire study period. Simple removal of necrotic slough and skin grafting is considered normal wound care and allowed.
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Interventions
The test product will be supplied as Telacebec 100mg tablets.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06481163