Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2018-001631-46-NL
EUCTR2018-001631-46-NL
Active, not recruiting
Phase 1

Implementation of pharmacokinetic-guided dosing of DDAVP and VWF-containing concentrates in von Willebrand disease - OPTI-CLOT: To Wi

Erasmus University Medical Center0 sites120 target enrollmentFebruary 13, 2019
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsVon Willebrand diseaseMedDRA version: 20.0Level: LLTClassification code 10055168Term: Von Willebrand's factor deficiencySystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
DrugsMinrinOctostimHaemate PWilateWilfactinVeyvondi

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Von Willebrand disease
Sponsor
Erasmus University Medical Center
Enrollment
120
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 13, 2019
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

Exclusion Criteria

  • •\- Any other known hemostatic abnormalities;
  • •\- Acquired VWD;
  • •\- Presence of VWF antibodies (\>0\.2 BU)
  • •\- Withdrawal of (parental) informed consent.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Implementation of pharmacokinetic-guided dosing of prophylaxis in hemophilia patients.HemophiliaMedDRA version: 20.0 Level: LLT Classification code 10060614 Term: Hemophilia B (Factor IX) System Organ Class: 100000004850MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
EUCTR2018-003869-33-NLErasmus University Medical Center50
Not yet recruiting
Not Applicable
Implementation of pharmacokinetic-guided dosing of prophylaxis in hemophilia patients
NL-OMON27791Erasmus Medical Center, Sophia Children's Hospital50
Not yet recruiting
Not Applicable
Implementation of pharmacokinetic-guided dosing of prophylaxis in hemophilia patients.
NL-OMON55874Erasmus MC, Universitair Medisch Centrum Rotterdam50
Recruiting
Not Applicable
Implementation of pharmacokinetic-guided dosing of DDAVP and VWF-containing concentrates in von Willebrand disease
NL-OMON54546Erasmus MC, Universitair Medisch Centrum Rotterdam160
Completed
Not Applicable
Development of a method for better estimation of warfarin dose in patients requiring warfarin therapyHealth Condition 1: null- atrial fibrillation and valve replacement patients requiring chronic anticoagulation therapy
CTRI/2018/06/014614Dr Nusrat Shafiq82