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NCT04023019RecruitingPhase 4

Treatment of Hemophilia A Patients With FVIII Inhibitors

MOdern Treatment of Inhibitor-PositiVe PATiEnts With Haemophilia A - An International Observational Study

Source: ClinicalTrials.gov · Last updated 23 Sept 2026

Brief summary (registry, in English)

This is a non-interventional, multicenter, observational, international study in male persons with haemophilia A who have developed inhibitors to any replacement coagulation factor VIII (FVIII) product. The purpose of the study is to capture different approaches in the management of persons with haemophilia A and FVIII inhibitors, document current immune tolerance induction approaches, and evaluate the efficacy and safety of immune tolerance induction, including the combination of FVIII and emicizumab. Patients will be assigned to 1 of 3 groups based on the treatments they receive, and may switch to another group if their treatment is changed. Participants will be followed after a maximum observational period of 5 years.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Observational
Enrollment
120 (estimated)
First submitted
12 Jul 2019
Start date
17 Mar 2020
Primary completion date
31 Dec 2028
Lead sponsor
Emory University
Diseases
Haemophilia
NCT number
NCT04023019
EU CT number
2024-516741-39-00
EudraCT number
2019-003427-38

What you commit to

  • Study type: Observational · Phase 4
  • Planned participants: 120
  • From 17 Mar 2020 to the primary completion date, 31 Dec 2028
  • 15 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Participants are excluded from the trial if any coagulation disorder other than haemophilia A is diagnosed
  • Partly retrospective patients will be excluded if detailed documentation on treatment, all bleeding episodes, inhibitor titers, and FVIII levels is not available for the retrospective period

Who the study is looking for

  • Male persons with haemophilia A, of any severity, who have a historical inhibitor titer ≥ 0.6 BU/mL, including those who have failed previous immune tolerance induction (ITI) attempt(s)
  • Persons undergoing ITI with Nuwiq, octanate, or wilateor undergoing ITI with Nuwiq®, octanate® or wilate® and receiving prophylactic therapy with emicizumab, activated prothrombin complex concentrate (aPCC), or activated recombinant factor VII (rFVIIa)
  • Participants or participants' parent(s)/legal guardian(s) must be capable of giving signed informed consent and be able to understand the trial documents

Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
Coordinator of this site? Confirm its status
SofiyaBulgariaCompleted
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
Gerinnungszentrum Rhein-Ruhr Aerztepartnerschaft Dr. med. Hannelore Rott Fachaerztin fuer Transfusionsmedizin Haemostaseologie Dr. med. Susan Halimeh Fachaerztin fuer Transfusionsmedizin Haemostaseologie Dr. med. Guenther Kappert Facharzt fuer Laboratoriumsmedizin Haemostaseologie
Coordinator of this site? Confirm its status
DuisburgGermanyRecruiting
HZRM Haemophilie-Zentrum Rhein Main GmbH
Coordinator of this site? Confirm its status
Frankfurt am MainGermanyRecruiting
Justus-Liebig-Universitaet Giessen
Coordinator of this site? Confirm its status
GiessenGermanyRecruiting
Universitaetsklinikum Muenster AöR
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MuensterGermanyRecruiting
Hospital General Universitario Dr. Balmis
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AlicanteSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Universitario San Juan de Alicante
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Sant Joan d'AlacantSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
HUS-Yhtymae
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HelsinkiFinlandCompleted
University Hospital Centre Zagreb
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ZagrebCroatiaRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
Region Skane Skanes Universitetssjukhus
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MalmoSwedenRecruiting
Arthur M Blank Hospital
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AtlantaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.