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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