Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
12
Countries
1
Sites
1
To restore coagulation in patients taking DOACs who are experiencing bleeding or who require reversal of anticoagulation prior to urgent surgery.
Key facts
- Sponsor
- VarmX B.V.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Trial duration
- 14 Aug 2024 → 13 Apr 2026
- Decision date (initial)
- 2024-05-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514339-87-00
- EudraCT number
- 2022-003675-41
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
To restore coagulation in patients taking DOACs who are experiencing bleeding or who require reversal of anticoagulation prior to urgent surgery.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10009773 | Coagulation factor X level | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
VarmX B.V.
- Sponsor organisation
- VarmX B.V.
- Address
- Emmy Noetherweg 2
- City
- Leiden
- Postcode
- 2333 BK
- Country
- Netherlands
Scientific contact point
- Organisation
- VarmX B.V.
- Contact name
- CMO
Public contact point
- Organisation
- VarmX B.V.
- Contact name
- CMO
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharma Bio-Research Group
Clinical Pharmacology, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-08-14 | 2026-04-13 | 2024-08-14 | 2024-10-30 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-17 | Netherlands | Acceptable 2024-05-29
|
2024-05-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-28 | Netherlands | Acceptable 2024-08-07
|
2024-08-07 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-02 | Netherlands | Acceptable 2024-08-07
|
2024-10-02 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-21 | Netherlands | Acceptable 2024-08-07
|
2025-10-21 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-02-03 | Netherlands | Acceptable 2024-08-07
|
2026-02-03 |