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NCT02912143 Clinical Trial

German Pediatric Hemophilia Research Database

Hemophilia A Clinical Trial

— GEPHARD  

Official title:
German Pediatric Hemophilia Research Database

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02912143
Other study ID # GEPHARD
Secondary ID DRKS00011101
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 31, 2028

Study information
Verified date March 2023
Source Goethe University
Contact Christoph Königs, PhD
Phone +496963018
Email christoph.koenigs@kgu.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 800
Est. completion date December 31, 2028
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - hemophilia A or B - FVIII/FIX <1% to 25% - informed consent Exclusion Criteria: - no consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• documentation only

Locations
Country Name City State
Germany Goethe University Frankfurt Hesse

Sponsors (2)
Lead Sponsor Collaborator
Goethe University Society for Thrombosis and Haemostasis Research (Germany)

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with antibody developement to exogenous clotting factors (>0.5 BU) Blood Test: measurement in Bethesda Units, positive according to local standards, for most labs > 0.5 BU 5 years
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