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Clinical trial

A Phase IIb, Open-Label, Randomized Controlled Dose Ranging Multi-Center Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Exposure-Response Relationship of Different Doses of BTZ-043 in Combination With Bedaquiline and Delamanid in Adult Subjects With Newly Diagnosed, Uncomplicated, Drug-sensitive Pulmonary Tuberculosis

NCT05926466 is registered in ClinicalTrials.gov with Michael Hoelscher as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase IIb, Open-Label, Randomized Controlled Dose Ranging Multi-Center Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Exposure-Response Relationship of Different Doses of BTZ-043 in Combination With Bedaquiline and Delamanid in Adult Subjects With Newly Diagnosed, Uncomplicated, Drug-sensitive Pulmonary Tuberculosis
Lead sponsor
Michael Hoelscher
Phase
Phase 2
Overall status
Completed
Start date
September 21, 2023
Completion date
December 27, 2024
Enrollment
92 (actual)
Sites
4

Conditions

As the registry lists them; a condition with its own page is linked.

other specified pulmonary tuberculosis, tuberculosis, pulmonary