German Pediatric Hemophilia Research Database | NCT02912143

Studies
German Pediatric Hemophilia Research Database

NCT02912143

Sponsor

Goethe University

Status

Recruiting

Last Update Posted

Mar 8, 2023Actual

Enrollment

800Estimated

Phase

Not provided

Conditions

Hemophilia A
Hemophilia B
Children
Drug Specific Antibodies

Interventions

documentation only

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DRKS00011101	Registry Identifier	DRKS

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Sep 17, 2016

First Submission Date that Met QC Criteria

Sep 20, 2016

First Posted Date

Sep 23, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2023

Last Update Posted Date

Mar 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christoph Königs, Consultant Pediatric Hemophilia Center, Goethe UniversityPrincipal Investigator

Lead Sponsor

Goethe UniversityOTHER

Collaborators

Name	Class
Society for Thrombosis and Haemostasis Research (Germany)	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
newly diagnosed children with hemophilia		no intervention	Other: documentation only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
documentation only	Other		newly diagnosed children with hemophilia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

no consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christoph Königs, PhD	Contact	+496963018	3030	christoph.koenigs@kgu.de
Christoph Bidlingmaier, MD	Contact	+498944005	2830	Christoph.bidlingmaier@med.uni-muenchen.de

Overall Officials

Name	Affiliation	Role
Christoph Königs, PhD	Goethe University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Goethe University	Recruiting	Frankfurt am Main	Hesse	60590	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006467	Hemophilia A
D002836	Hemophilia B

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided