Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06481163 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Telacebec (T) Treatment in Adults With Buruli Ulcer (BU). (TREAT BU)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria revisedv10
  2. Primary completion date: Dec 2026 to Dec 2027v9 Show 6 more changesShow less
    • Enrollment target: 140 to 200
    • Study completion date: Dec 2026 to Jan 2028
    • Eligibility criteria expanded, about 73 words
    • Secondary endpoints: 4 to 2
    • Study description expanded, about 13 words
    • Study title expanded, about 2 words
  3. Enrollment target: 120 to 140
    • Secondary endpoints: 3 to 4
    • Study description expanded, about 14 words
    • Site contacts updated at 1 of 2 sites
    v8
  4. Trial status: Active, Not Recruiting to Recruitingv7 Show 6 more changesShow less
    • Enrollment target: 40 to 120
    • Primary and study completion dates: Dec 2025 to Dec 2026
    • Eligibility criteria shortened, about 41 words
    • Secondary endpoints: 5 to 3
    • Study description shortened, about 57 words
    • Site details revised at 2 of 2 sites
  5. Primary completion date: Dec 2024 to Dec 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Site details revised at 1 of 2 sitesv5
  2. Site details revised at 1 of 2 sitesv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Jul 2024 to Jul 9, 2024
    v3
  4. Start date: Jun 2024 to Jul 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 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.
Trial Details
NCT Number NCT06481163
Lead Sponsor Barwon Health
Collaborators: Global Alliance for TB Drug Development
Conditions
(from sponsor)		 Buruli Ulcer
Related terms Buruli Ulcer, Ulcer
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov