Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
20
Countries
1
Sites
4
idiopathic pulmonary fibrosis
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Dijon
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 20 Mar 2023 → 20 Feb 2025
- Decision date (initial)
- 2024-08-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515303-19-00
- EudraCT number
- 2021-005454-28
- ClinicalTrials.gov
- NCT05331729
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
idiopathic pulmonary fibrosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10021240 | Idiopathic pulmonary fibrosis | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Dijon
- Sponsor organisation
- Centre Hospitalier Universitaire De Dijon
- Address
- 1 Boulevard Jeanne D Arc, Bp 77908 Bp 77908
- City
- Dijon
- Postcode
- 21000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Dijon
- Contact name
- Chef de projets recherche
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Dijon
- Contact name
- Chef de projets recherche
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 20 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Dijon
Pneumologie et soins intensifs respiratoires, 1 Boulevard Jeanne D Arc, Bp 77908, Dijon
Centr Georges Francois Leclerc
Médecine nucléaire, 1 Rue Professeur Marion, 21000, Dijon
Centre Hospitalier Universitaire De Dijon
Pneumologie et soins intensifs respiratoires, 1 Boulevard Jeanne D Arc, Bp 77908, Dijon
Centre Hospitalier Universitaire De Dijon
CIC-P, 1 Boulevard Jeanne D Arc, Bp 77908, Dijon
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2023-03-20 | 2025-02-20 | 2023-03-20 | 2024-11-07 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-13 | France | Acceptable 2024-08-26
|
2024-08-26 |