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
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Specialized Hospital For Active Treatment Of Hematological Diseases EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| 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 | Duisburg | Germany | Recruiting |
| HZRM Haemophilie-Zentrum Rhein Main GmbH Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Justus-Liebig-Universitaet Giessen Coordinator of this site? Confirm its status | Giessen | Germany | Recruiting |
| Universitaetsklinikum Muenster AöR Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario San Juan de Alicante Coordinator of this site? Confirm its status | Sant Joan d'Alacant | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Completed |
| University Hospital Centre Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Malmo | Sweden | Recruiting |
| Arthur M Blank Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.