Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
10
Countries
1
Sites
1
Primary ciliary dyskinesia
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Decision date (initial)
- 2024-09-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513197-22-02
- WHO UTN
- U1111-1303-6004
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Primary ciliary dyskinesia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10069713 | Primary ciliary dyskinesia | 100000004850 |
| 20.0 | PT | 10011762 | Cystic fibrosis | 100000004850 |
| 22.1 | LLT | 10035691 | Pneumonia due to pseudomonas | 10021881 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Tavs Qvist
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Tavs Qvist
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Rigshospitalet
Department of Infectiuos Diseseases, Blegdamsvej 9, 2100, Copenhagen Oe
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-11 | Denmark | Acceptable 2024-09-13
|
2024-09-13 |