Dynamics of the Anti-factor VIII Antibody Signature During Treatment With Emicizumab
NCT ID: NCT05802836
Last Updated: 2023-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-04-26
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Inhibitor negative, FVIII on demand or regularly
Patients with severe hemophilia A receiving emicizumab therapy which are negative for factor VIII Inhibitor (including patients post ITI) and are receiving factor VIII therapy either on demand or regularly,
no interventions
no intervention, only 3 different patients groups
Inhibitor positive, FVIII therapy regularly (ITI)
Patients with severe hemophilia A receiving emicizumab therapy which are positive for factor VIII Inhibitor and are receiving regularly factor VIII therapy (ITI)
no interventions
no intervention, only 3 different patients groups
Inhibitor positive, no FVIII therapy
Patients with severe hemophilia A receiving emicizumab therapy which are positive for factor VIII Inhibitor and are receiving no factor VIII therapy
no interventions
no intervention, only 3 different patients groups
Interventions
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no interventions
no intervention, only 3 different patients groups
Eligibility Criteria
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Inclusion Criteria
* Treatment with emicizumab irrespective of any other treatment
* Informed consent
Exclusion Criteria
* Immunosuppressive therapy
* HIV-infection with CD4 (cluster of differentiation 4) cells \<200/µl
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Chugai Pharma Germany GmbH
UNKNOWN
Christoph Königs
OTHER
Responsible Party
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Christoph Königs
Principal Investigator, Head of molecular and clinical Haemostasis
Principal Investigators
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Christoph Koenigs, PD Dr. Dr
Role: PRINCIPAL_INVESTIGATOR
Goethe University
Locations
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University Hospital Frankfurt, Goethe University
Frankfurt am Main, Hesse, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DRKS00031196
Identifier Type: REGISTRY
Identifier Source: secondary_id
ML44394
Identifier Type: -
Identifier Source: org_study_id
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