Ignite Creation Date:
2024-07-17 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481163
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-21
Brief Title:
Telacebec T Treatment in Adults with Buruli Ulcer BU
Sponsor:
Barwon Health
Organization:
Barwon Health
Study Overview
Official Title:
A Phase 2 Multicentre Open-label Study to Evaluate the Efficacy Safety and Tolerability and Pharmacokinetics of 28 Days Telacebec Treatment in Adult Participants with Buruli Ulcer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREAT-BU
Brief Summary:
The goal of this interventional clinical trial is to determine if treatment with 4 weeks of telacebac T will completely heal lesions in participants with Buruli ulcer BU by 52 weeks after treatment initiation without relapse andor surgery Males and females age 18 and older will be included
Participants will attend visits every week during treatment 4 weeks
Thereafter they will be followed every 2 weeks until week 24 followed by visits as weeks 30 40 and 52
Dependent on site requirements there may be follow up visits on site or remotely
Participants will attend visits every week during treatment 4 weeks
Thereafter they will be followed every 2 weeks until week 24 followed by visits as weeks 30 40 and 52
Dependent on site requirements there may be follow up visits on site or remotely
Detailed Description:
This is an open label single arm telacebec multi-centre clinical trial Eligible participants with clinically diagnosed World Health Organization WHO category I lesions and category II lesions 10 cm cross-sectional diameter and category III lesions where multiple and all lesions are 10 cm cross-sectional diameter confirmed by polymerase chain reaction PCR or culture for presence of Mycobacterium ulcerans infection will receive telacebec 300 mg orally once daily for 28 days with food
Participants who meet entry criteria and give consent will attend a baseline enrolment visit Day 1 then visits every week for 4 weeks during treatment weeks 1 2 3 and 4 Thereafter they will be followed up every 2 weeks until week 24 followed by visits at weeks 30 40 and 52
BU lesion management will be provided to all trial participants In case of participant early withdrawal from the trial during or after the treatment period participants will be treated per the investigational site andor country BU treatment guidelines
A Data Review Committee DRC will be established to review efficacy and safety data Enrolment and enrolled participants will continue the study whilst the DRC reviews are ongoing
Participants who meet entry criteria and give consent will attend a baseline enrolment visit Day 1 then visits every week for 4 weeks during treatment weeks 1 2 3 and 4 Thereafter they will be followed up every 2 weeks until week 24 followed by visits at weeks 30 40 and 52
BU lesion management will be provided to all trial participants In case of participant early withdrawal from the trial during or after the treatment period participants will be treated per the investigational site andor country BU treatment guidelines
A Data Review Committee DRC will be established to review efficacy and safety data Enrolment and enrolled participants will continue the study whilst the DRC reviews are ongoing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None