Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
15
Countries
1
Sites
11
Chronic venous insufficiency
Key facts
- Sponsor
- VeriGraft AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 25 Feb 2021 → 11 Jun 2025
- Decision date (initial)
- 2024-12-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520148-40-00
- EudraCT number
- 2020-003778-28
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic venous insufficiency
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10066682 | Chronic venous insufficiency | 10047065 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
VeriGraft AB
- Sponsor organisation
- VeriGraft AB
- Address
- Arvid Wallgrens Backe 20, Goteborgs Annedal Goteborgs Annedal
- City
- Goteborg
- Postcode
- 413 46
- Country
- Sweden
Scientific contact point
- Organisation
- VeriGraft AB
- Contact name
- Raimund Strehl
Public contact point
- Organisation
- VeriGraft AB
- Contact name
- Raimund Strehl
Locations
1 EU/EEA country · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 15 | 11 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario Virgen De Las Nieves
Servicio de Angiología y Cirugía vascular, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Universitario Puerta Del Mar
Servicio de Angiología y Cirugía vascular, Avenida De Ana De Viya 21, 11009, Cadiz
Hospital Universitario Clinico San Cecilio
Servicio de Angiología y Cirugía vascular, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Universitario De Jaen
Servicio de Angiología y Cirugía vascular, Avenida Del Ejercito Espanol 10, 23007, Jaen
Hospital Universitario Torrecardenas
Servicio de Angiología y Cirugía vascular, Calle Paraje Torrecardenas S/n, 04009, Almeria
Hospital Universitario Virgen De La Victoria
Servicio de Angiología y Cirugía vascular, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitario Virgen De Valme
Servicio de Angiología y Cirugía vascular, Avenida Bellavista S/n, 41014, Sevilla
University Hospital Virgen Del Rocio S.L.
Servicio de Angiología y Cirugía vascular, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Del Mar
Servicio de Angiología y Cirugía vascular, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitari Vall D Hebron
Servicio de Angiología y Cirugía vascular, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Bellvitge University Hospital
Servicio de Angiología y Cirugía vascular, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
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 |
|---|---|---|---|---|---|
| Spain | 2021-02-25 | 2025-06-11 | 2021-10-18 | 2025-05-14 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-16 | Spain | Acceptable 2024-12-23
|
2024-12-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-06 | Spain | Acceptable 2025-05-14
|
2025-05-14 |