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

Официальное название

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.

Обзор

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.

Подробное описание

This is an open label single arm (telacebec), phase 2 multi-centre, clinical trial. Eligible participants with clinically diagnosed BU, confirmed by polymerase chain reaction (PCR) or culture presence of MU infection will receive telacebec 300 mg orally once daily for 14-28 days with food (protocol V2.0 - 6.0) or telacebec 100 mg orally once daily for 10 days with food (protocol V7.0).

Participants who meet entry criteria and give consent will attend a baseline enrolment visit (Day 1), then visits every week for 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 and/or country BU treatment guidelines.

A Data Review Committee (DRC) will review efficacy and safety data. Enrolment and enrolled participants will continue the study whilst the DRC reviews are ongoing.

Вмешательства

• Препарат Telacebec
  The test product will be supplied as Telacebec 100mg tablets.

Первичные конечные точки

• Rate of complete lesion healing by 52 weeks from treatment initiation. [Срок оценки: 52 weeks from treatment initiation]

Вторичные конечные точки (2)

• Median time to healing [Срок оценки: 52 weeks from treatment initiation]
• Safety and Tolerability [Срок оценки: Time of first dose to 28 days after last dose of telacebec.]

Критерии участия

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 culture for confirmation of presence of mycobacterium ulcerans (MU).
• Aged 18 years and older, except for those included in exclusion below.

Major Exclusion Criteria:

• Participants with the following known or suspected medical conditions/criteria:

• 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 \[estimated glomerular filtration rate (eGFR) < 30 mls/min\],
• Compromised immune status (e.g. uncontrolled HIV-infection)
• History of previous BU in the previous 12 months (except current infection)
• Participants who fulfill both of the following criteria:

• Aged ≥ 60 years
• Weight ≥ 85 kg
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 2 центра

• Barwon Health — Geelong
• Royal Melbourne Hospital — Melbourne

Идентификаторы

NCT: NCT06481163 · TBA-BU-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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