NCT04023019 Treatment of Hemophilia A Patients With FVIII Inhibitors
| NCT ID | NCT04023019 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Hemophilia A |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2020-03-17 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2020-03-17 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Robert Sidonio, MD, MSc
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT04023019 clinical trial?
This trial is open to male participants only, studying Hemophilia A. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04023019 currently recruiting?
Yes, NCT04023019 is actively recruiting participants. Contact the research team at robert.sidonio.jr@emory.edu for enrollment information.
Where is the NCT04023019 trial being conducted?
This trial is being conducted at Atlanta, United States, Mörfelden-Walldorf, Germany.
Who is sponsoring the NCT04023019 clinical trial?
NCT04023019 is sponsored by Emory University. The principal investigator is Robert Sidonio, MD, MSc at Emory University. The trial plans to enroll 120 participants.