Actively Recruiting
A Study of the Early Effects, Safety, and Acceptability of Oral Alpibectir in Combination With Ethionamide
Led by TASK Applied Science · Updated on 2025-03-07
60
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
T
TASK Applied Science
Lead Sponsor
I
Innovative Medicines Initiative
Collaborating Sponsor
AI-Summary
What this Trial Is About
A multi-centre, randomized, open-label clinical trial. All treatments will be administered orally (PO) on days 1-14. 15 participants will be recruited into each treatment arm in two sequential cohorts. Each cohort will have participants enrolled onto the experimental regimen(s) or the standard of care (SOC; HRZE) control arm. • Cohort 1 aims to generate safety data for a higher dose of alpibectir plus ethionamide 125 mg and 250 mg (arm 1: A45E125 and arm2: A45E250). Once 5 participants have enrolled into arms 1 and 2 each, and completed 14 days of treatment, an interim safety review will be conducted to determine whether the study can advance to cohort 2. • Cohort 2 will investigate safety of alpibectir and ethionamide (A45E250) in combination with rifampicin, pyrazinamide and ethambutol (A45E250RZE). Participants on HRZE will serve as control for the EBA quantitative mycobacteriology in each cohort, and additionally as a safety benchmark for the A45E250RZE arm. The study is not statistically powered to make between arm comparisons of activity or safety. The treatment will not be blinded but the mycobacteriology laboratory staff performing the endpoint assays will remain blinded until analysis of the EBA results.
CONDITIONS
Official Title
A Study of the Early Effects, Safety, and Acceptability of Oral Alpibectir in Combination With Ethionamide
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written, informed consent and agree to follow study procedures throughout the trial
- Male or female aged between 18 and 65 years
- Body weight between 40 and 90 kg
- Newly diagnosed and untreated pulmonary tuberculosis for this episode
- Rifampicin- and isoniazid-susceptible pulmonary TB confirmed by molecular tests
- Chest X-ray consistent with TB within 2 weeks before screening
- GeneXpert test positive with medium or high bacterial load
- Able to produce at least 10 ml of sputum from overnight collection
- Non-childbearing potential or using effective birth control if of childbearing potential
- Female participants of childbearing potential must use injectable or other approved contraception before first dose
- Male participants must refrain from donating fresh unwashed semen and use condoms during treatment and for 90 days after last dose
You will not qualify if you...
- Clinically significant conditions other than TB that affect safety or trial outcome
- Poor general condition where treatment delay is unsafe
- History of epilepsy, seizures, or neuropsychiatric disorders
- Cirrhosis or unstable liver/biliary disease
- History of hypothyroidism
- QTcF interval greater than 450 ms at baseline
- Evidence of extra-thoracic TB
- Allergy to any trial medication
- Alcohol or drug abuse compromising safety or cooperation
- HIV positive with CD4 count under 250 cells/mm3, on disallowed ART, or unwilling to start ART
- Pregnant, breastfeeding, or planning pregnancy within study period plus 90 days
- Participation in other investigational drug studies within 8 weeks before screening
- Previous treatment for this TB episode with active TB drugs
- Recent use of immunosuppressive medications or corticosteroids
- Use of prohibited concomitant medications during the study
- Positive hepatitis B or C tests
- Laboratory abnormalities including elevated creatinine, low hemoglobin or platelets, abnormal potassium, liver enzymes, bilirubin, white cell counts, thyroid hormone, or low glucose levels
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
TASK
Cape Town, Western Cape, South Africa, 7550
Actively Recruiting
Research Team
G
Gifty Okyere-Manu, MBChB
CONTACT
V
Vani Govender, Masters Medical Science
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here