Effects of pharmacokinetic models in dosing of DDAVP and/or von Willebrand factor-containing concentrates in patients with von Willebrand disease

Phase 1

• Conditions: Von Willebrand disease; MedDRA version: 20.0Level: LLTClassification code 10055168Term: Von Willebrand's factor deficiencySystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-001631-46-NL
• Lead Sponsor: Erasmus University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-13
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

-VWD and low VWF patient of all ages, with all types of VWD and low VWF”;
-Undergoing a DDAVP-test, and/or
-Undergoing a medical intervention requiring treatment with DDAVP and/or VWF-containing concentrates with monitoring of FVIII and VWF levels. Medical interventions may include: dental, surgical or diagnostic procedures, and child deliveries in the hospital setting as examples. , or
-With bleeding requiring treatment with DDAVP and/or VWF-containing concentrate with monitoring of FVIII and VWF levels, or
-Requiring a PK profile for future medical intervention or bleeding episode, or
-With prescribed or requiring prophylaxis with VWF-containing concentrate due to bleeding frequency.

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 68
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 20

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 clinical trial of medicinal product
• Study Design: Not specified