Clinical trial • Phase III • Respiratory | Infectious Disease | Other

Clinical trial in Primary ciliary dyskinesia | Chronic pulmonary Pseudomonas aeruginosa infection | Cystic fibrosis

Phase III trial for Primary ciliary dyskinesia | Chronic pulmonary Pseudomonas aeruginosa infection | Cystic fibrosis. None/Not specified-controlled.

Overview

Trial Therapeutic Area
Respiratory | Infectious Disease | Other
Trial Disease
Primary ciliary dyskinesia | Chronic pulmonary Pseudomonas aeruginosa infection | Cystic fibrosis
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
11-06-2024
First CTIS Authorization Date
13-09-2024

Trial design

None/Not specified-controlled Phase III trial across 1 site in Denmark.

Comparator
None/Not specified
Target Sample Size
10

Eligibility

Recruits 10 Vulnerable population not selected; no specific vulnerable population considerations or consent/assent handling described..

Vulnerable Population
Vulnerable population not selected; no specific vulnerable population considerations or consent/assent handling described.

Recruitment

Planned Sample Size
10
Recruitment Window Months
28

Geography

Total Number Of Sites
1
Total Number Of Participants
10

Denmark

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
13-09-2024
Processing Time Days
7
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Rigshospitalet
Department Name
Department of Infectiuos Diseseases
Principal Investigator Name
Tavs Qvist
Principal Investigator Email
tavs.qvist@regionh.dk
Contact Person Name
Tavs Qvist
Contact Person Email
tavs.qvist@regionh.dk
Number Of Participants
10

Sponsor

Primary sponsor

Full Name
Rigshospitalet
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

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