Implementation of pharmacokinetic-guided dosing of prophylaxis in hemophilia patients.

Phase 1

• Conditions: Hemophilia; MedDRA version: 20.0 Level: LLT Classification code 10060614 Term: Hemophilia B (Factor IX) System Organ Class: 100000004850; MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-003869-33-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: 2018-12-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

- Hemophilia A and B patients of all ages on prophylaxis;
-Prophylaxis with SHL factor concentrate or EHL factor concentrate;
-Written (parental) informed consent, according to local law and regulations

Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

-Patients with other congenital or acquired hemostatic abnormalities;
-General medical conditions which may interfere with participation in the study;
-Inability to adhere to prophylaxis and/ or inability to keep detailed logs of infusions and bleeding episodes;
-Withdrawal of (parental) informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified