Study of Pharmacokinetic-guided dosing of clottiing factor in Hemophilia.

Phase 1

• Conditions: Hemophillia; MedDRA version: 20.0Level: LLTClassification code 10066439Term: HemophiliaSystem Organ Class: 100000004850; MedDRA version: 20.0Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000004850; MedDRA version: 20.0Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-000909-24-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-24
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 72

Inclusion Criteria

- Severe and moderate hemophilia A or B (FVIII/FIX plasma level = 5%)
- Elective and low or medium risk surgery as defined by surgical risk score (form B)
- = 12 years of age at inclusion date for the randomized controlled trial;
- < 12 years of age at inclusion date for the PK-guided dosing observational children cohort.
- Written informed consent.

Are the trial subjects under 18? yes
Number of subjects for this age range: 72
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with other congenital or acquired hemostatic abnormalities.
- Withdrawal of (parental) informed consent.
- Detectable FVIII/FIX inhibiting antibodies (>0.02 BU) at inclusion in study.
- General medical conditions which may interfere with participation in the study.

Study & Design

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