BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA)
A Prospective Phase Ib/IIa, Active-controlled, Randomized, Open-label Study to Evaluate the Safety, Tolerability, Extended Early Bactericidal Activity and Pharmacokinetics of Multiple Oral Doses of BTZ-043 Tablets in Subjects With Newly Diagnosed, Uncomplicated, Smear-positive, Drug-susceptible Pulmonary Tuberculosis
Sponsor: European and Developing Countries Clinical Trials Partnership (EDCTP)
A PHASE1/PHASE2 clinical study on Other Specified Pulmonary Tuberculosis and Pulmonary Tuberculoses, this trial is completed. The trial is conducted by European and Developing Countries Clinical Trials Partnership (EDCTP) and has accumulated 10 data snapshots since 2019. Infectious disease trials contribute critical data for public health response and treatment development.
Status Flow
Change History
10 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1/PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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Sep 2022 — Jul 2024 [monthly]
Completed PHASE1_PHASE2
Status: Active Not Recruiting → Completed
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Mar 2022 — Sep 2022 [monthly]
Active Not Recruiting PHASE1_PHASE2
Status: Recruiting → Active Not Recruiting
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Nov 2021 — Mar 2022 [monthly]
Recruiting PHASE1_PHASE2
▶ Show 5 earlier versions
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Jan 2021 — Nov 2021 [monthly]
Recruiting PHASE1_PHASE2
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Dec 2020 — Jan 2021 [monthly]
Recruiting PHASE1_PHASE2
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Jan 2020 — Dec 2020 [monthly]
Recruiting PHASE1_PHASE2
-
Dec 2019 — Jan 2020 [monthly]
Recruiting PHASE1_PHASE2
Status: Not Yet Recruiting → Recruiting
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Sep 2019 — Dec 2019 [monthly]
Not Yet Recruiting PHASE1_PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- German Federal Ministry of Education and Research
- Michael Hoelscher
- Radboud University Medical Center
For direct contact, visit the study record on ClinicalTrials.gov .