Implementation of pharmacokinetic-guided dosing of DDAVP and VWF-containing concentrates in von Willebrand disease

Recruiting

• Conditions: bleeding disorder; von Willebrand disease; 10005330

• Registration Number: NL-OMON54546
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

- No minimum or maximum age at inclusion date;
- Hemorrhagic symptoms or a family history of von Willebrand disease with
historically lowest levels of VWF:Ag <0.60 IU/ml and/or VWF:Act <0.60 IU/ml
and/or VWF:CB <0.60 and/or FVIII <0.40 IU/ml;
- Need for DDAVP-testing (arm A); and/or
- Need for a medical intervention requiring DDAVP and/or VWF replacement
therapy (arm B) (arm B); or
- (Future) Bleeding requiring DDAVP and/or VWF replacement therapy (arm C); or
- Receiving or requiring prophylaxis with VWF-containing concentrate due severe
and/or recurrent bleeding episode (arm D).
- Written patient (and in case of a patient <16 years of age, parental)
informed consent.

Exclusion Criteria

- Any other known hemostatic abnormalities;
- Acquired VWD;
- Presence of VWF antibodies (>0.2 BU)
- Withdrawal of (parental) informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified