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RecruitingNCT02912143GEPHARDUpdated Mar 8, 2023

German Pediatric Hemophilia Research Database

An observational study in Hemophilia A, Hemophilia B and Children, sponsored by Goethe University. Recruiting at 1 site in Germany. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by Goethe University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
Up to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hemophilia A
  • Hemophilia B
  • Children
  • Drug Specific Antibodies
03

In context

Hemophilia A

866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.

This study's planned enrollment of 800 is above the median of 80 across 314 observational studies indexed under Hemophilia A.

Browse Hemophilia A studies →

Lead sponsor

Goethe University is the lead sponsor of 97 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All children between 0 and 18 yrs diagnosed with hemophilia A or B (FVIII/FIX \< 1% to 25%) from 01.01.2017.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • no consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • newly diagnosed children with hemophilia

    no intervention

    Other: documentation only

Interventions

  • Otherdocumentation only
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Goethe University
    Frankfurt, Hesse 60590, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual Patient data will not be shared outside specified collaborating studies (none yet)

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02912143
Lead sponsor
Goethe University
Collaborators
Society for Thrombosis and Haemostasis Research (Germany)
Responsible party
Christoph Königs (Consultant Pediatric Hemophilia Center, Goethe University) — Principal investigator
First posted
Sep 23, 2016
Start date
Jan 1, 2017
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Mar 8, 2023

Study contacts

Christoph Königs, PhD
Contact
christoph.koenigs@kgu.de
+496963018 ext. 3030
Christoph Bidlingmaier, MD
Contact
Christoph.bidlingmaier@med.uni-muenchen.de
+498944005 ext. 2830
Christoph Königs, PhD
principal investigator · Goethe University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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