German Pediatric Hemophilia Research Database (GEPHARD)

August 8, 2022 updated by: Christoph Königs, Goethe University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Hesse
      • Frankfurt, Hesse, Germany, 60590

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • no consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
newly diagnosed children with hemophilia
no intervention
Other: documentation only

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goethe University

Collaborators

Society for Thrombosis and Haemostasis Research (Germany)

Investigators

  • Principal Investigator: Christoph Königs, PhD, Goethe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

December 31, 2027

Study Completion (Anticipated)

December 31, 2028

Study Registration Dates

First Submitted

September 17, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEPHARD
  • DRKS00011101 (Registry Identifier: DRKS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Patient data will not be shared outside specified collaborating studies (none yet)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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