Clinical trial • Phase III • Respiratory

Clinical trial in Tuberculosis

Phase III trial for Tuberculosis. 32 participants.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Tuberculosis
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
16-06-2025
First CTIS Authorization Date
19-09-2025

Trial design

Phase III trial across 2 sites in Bulgaria.

Target Sample Size
32

Eligibility

Recruits 32 Vulnerable population not selected (isVulnerablePopulationSelected: false). No information on consent or assent provided in source data..

Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected: false). No information on consent or assent provided in source data.

Recruitment

Planned Sample Size
32
Recruitment Window Months
9
Consent Approach
Not specified in source data.

Geography

Total Number Of Sites
2
Total Number Of Participants
32

Bulgaria

Latest Decision Or Authorization Date
05-03-2026
Number Of Sites
2
Number Of Participants
32

Sites

Site Name
Medical Center Comac Medical Ltd.
Department Name
Medical Center Comac Medical Ltd
Contact Person Name
Maya Dabcheva
Site Name
Medical Center Comac Medical Ltd.
Department Name
Medical Center Comac Medical Ltd
Contact Person Name
Maya Dabcheva

Sponsor

Primary sponsor

Full Name
Otsuka Pharmaceutical Development & Commercialization Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

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