Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
20
Countries
1
Sites
1
Hemodialys
Key facts
- Sponsor
- Region Oestergoetland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 12 Dec 2023 → 30 Aug 2024
- Decision date (initial)
- 2023-08-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Hemodialys
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10065586 | Skin disinfection | 10042613 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Oestergoetland
- Sponsor organisation
- Region Oestergoetland
- Address
- Universitetssjukhuset 1
- City
- Linkoping
- Postcode
- 581 85
- Country
- Sweden
Scientific contact point
- Organisation
- Region Oestergoetland
- Contact name
- Fredrik Uhlin
Public contact point
- Organisation
- Region Oestergoetland
- Contact name
- Fredrik Uhlin
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Sweden | 2023-12-12 | 2024-08-30 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-12 | Sweden | Acceptable 2023-08-14
|
2023-08-16 |