Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
48
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, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 21 Feb 2024 → ongoing
- Decision date (initial)
- 2023-11-17
- 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
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
- Middelweg 38 B
- City
- Leiden
- Postcode
- 2312 KJ
- Country
- Netherlands
Scientific contact point
- Organisation
- VarmX B.V.
- Contact name
- Clinical trial information desk
Public contact point
- Organisation
- VarmX B.V.
- Contact name
- Clinical trial information desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 48 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
QPS Netherlands B.V.
Clinical Pharmacology, Hanzeplein 1, 9713 GZ, 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 | 2024-02-21 | 2024-02-21 | 2024-07-01 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-20 | Netherlands | Acceptable 2023-11-17
|
2023-11-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-18 | Netherlands | Acceptable 2024-02-14
|
2024-02-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-18 | Netherlands | Acceptable 2024-05-15
|
2024-05-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-11 | Netherlands | Acceptable 2024-07-02
|
2024-07-02 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-02 | Netherlands | Acceptable 2024-07-02
|
2024-10-02 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-21 | Netherlands | Acceptable 2024-07-02
|
2025-10-21 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-02-03 | Netherlands | Acceptable 2024-07-02
|
2026-02-03 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-05-18 | Netherlands | Acceptable 2024-07-02
|
2026-05-18 |