Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
21
Countries
4
Sites
6
Hemophilia
Key facts
- Sponsor
- Tiumbio Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 10 Dec 2024 → ongoing
- Decision date (initial)
- 2025-03-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Hemophilia
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tiumbio Co. Ltd.
- Sponsor organisation
- Tiumbio Co. Ltd.
- Address
- 49 Daewangpangyo-Ro 644beon-Gil, Bundang-Gu Bundang-Gu
- City
- Seongnam-Si
- Postcode
- 13493
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Tiumbio Co. Ltd.
- Contact name
- Heeyeon Jung
Public contact point
- Organisation
- Tiumbio Co. Ltd.
- Contact name
- Heeyeon Jung
Locations
4 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruiting | 3 | 1 |
| Italy | Authorised, recruitment pending | 8 | 1 |
| Romania | Ended | 2 | 1 |
| Spain | Authorised, recruiting | 8 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
III Department of Clinical Hematology, Bulevard Kliment Ohridski 1a, 1797, Sofiya
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Hematologie, Strada Republicii 34-36, 400015, Cluj-Napoca
Hospital Universitario Regional De Malaga
Hematology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 |
|---|---|---|---|---|---|
| Bulgaria | 2025-07-17 | ||||
| Spain | 2024-12-10 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-RO-0001
- Member state
- Romania
- Publication date
- 2025-03-12
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- Phase I clinical trial should be conducted in authorized units according to MoH 3390/08.11.2022
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-19 | Spain | Acceptable with conditions 2024-07-08
|
2024-07-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-07 | Spain | Acceptable 2024-10-23
|
2024-10-23 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-12-19 | Acceptable 2024-10-23
|
2025-03-18 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-12-19 | Acceptable 2024-10-23
|
2025-02-25 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-19 | Spain | Acceptable 2024-10-23
|
2025-03-19 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-25 | Spain | Acceptable 2024-10-23
|
2025-03-25 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-07 | Spain | Acceptable 2025-07-14
|
2025-07-14 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-09-18 | Spain | Acceptable 2025-07-14
|
2025-09-18 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-12-19 | Spain | Acceptable 2025-07-14
|
2025-12-19 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-01-29 | Spain | Acceptable 2025-07-14
|
2026-01-29 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-01-29 | Acceptable 2025-07-14
|
2026-01-29 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-01-30 | Spain | Acceptable 2026-05-08
|
2026-05-12 |