German Pediatric Hemophilia Research Database

Recruiting

• Conditions: Hemophilia B; Hemophilia A; Children; Drug Specific Antibodies
• Interventions: Other: documentation only

• Registration Number: NCT02912143
• Lead Sponsor: Goethe University

Brief Summary

The German Pediatric Hemophilia Research Database will collect data on the prophylactic and therapeutic use of factor concentrates, complications, outcome measures (joint scores, QoL) and living circumstances in newly diagnosed children with hemophilia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-17
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-23
• Study Start: 2017-01-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-08
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• hemophilia A or B
• FVIII/FIX <1% to 25%
• informed consent

Exclusion Criteria

• no consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
newly diagnosed children with hemophilia	documentation only	no intervention

Primary Outcome Measures

Name	Time	Method
Number of patients with antibody developement to exogenous clotting factors (>0.5 BU)	5 years	Blood Test: measurement in Bethesda Units, positive according to local standards, for most labs \> 0.5 BU

Trial Locations

Locations (1)

Goethe University; 🇩🇪 Frankfurt, Hesse, Germany