Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
8
Countries
1
Sites
1
graft-versus-host disease
Key facts
- Sponsor
- Red De Apoyo A La Investigacion Clinica En Hematologia Y Hemoterapia S.L., Vall D Hebron Institute Of Oncology
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02], Diseases [C] - Neoplasms [C04], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 17 Dec 2025 → ongoing
- Decision date (initial)
- 2025-06-27
- 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
graft-versus-host disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Red De Apoyo A La Investigacion Clinica En Hematologia Y Hemoterapia S.L.
- Sponsor organisation
- Red De Apoyo A La Investigacion Clinica En Hematologia Y Hemoterapia S.L.
- Address
- Calle De Aravaca 12 Piso 1 B
- City
- Madrid
- Postcode
- 28040
- Country
- Spain
Scientific contact point
- Organisation
- Red De Apoyo A La Investigacion Clinica En Hematologia Y Hemoterapia S.L.
- Contact name
- scientific information
Public contact point
- Organisation
- Red De Apoyo A La Investigacion Clinica En Hematologia Y Hemoterapia S.L.
- Contact name
- scientific information
Vall D Hebron Institute Of Oncology
- Sponsor organisation
- Vall D Hebron Institute Of Oncology
- Address
- Calle Natzaret 115
- City
- Barcelona
- Postcode
- 08035
- Country
- Spain
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 8 | 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 |
|---|---|---|---|---|---|
| Spain | 2025-12-17 | 2026-02-16 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-08 | Spain | Acceptable 2025-06-27
|
2025-06-27 |