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NCT04023019 · ClinicalTrials.gov registry record
Treatment of Hemophilia A Patients With FVIII Inhibitors
A clinical trial of Hemophilia A, sponsored by Emory University.
- Recruiting
- Registry status
- 120
- Enrollment target
- 2
- Study locations
NCT04023019: Recruiting study of Hemophilia A, sponsored by Emory University.
NCT04023019 is a study of Hemophilia A that is actively recruiting participants, run by Emory University. The registered enrollment target is 120 participants, above the 89-participant average among 42 other Hemophilia A trials with a reported enrollment target (35% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04023019, a study of Hemophilia A, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- 120 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
The proportion of participants in Groups 1 and 2 achieving inhibitor titer \< 0.6 Bethesda units (BU)/mL L for at least 2 consecutive measurements will be determined. FVIII inhibitor titer is measured at baseline and throughout the study, according to standard of care.
Conditions Studied
Interventions
- BIOLOGICAL Emicizumab
- BIOLOGICAL Nuwiq
- BIOLOGICAL Octanate
- BIOLOGICAL Wilate
- BIOLOGICAL Recombinant factor VIIa (rFVIIa)
Study Locations (2)
Georgia
- Arthur M. Blank Hospital - Atlanta
Other
- HZRM Hämophilie-Zentrum Rhein Main - Mörfelden-Walldorf
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2020-03-17 |
| Est. Completion | 2029-06 |
What NCT04023019 shows while recruiting
NCT04023019 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 89-participant average among 42 other Hemophilia A trials with a reported enrollment target (35% higher).
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 5 interventions - of which Emicizumab is the first listed.
NCT04023019 reports a single indexed study location in Georgia, Other.
Frequently Asked Questions
What is clinical trial NCT04023019 about?
NCT04023019 is a clinical study titled "Treatment of Hemophilia A Patients With FVIII Inhibitors". 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 hae...
What is the current status of trial NCT04023019?
This trial is currently recruiting. The enrollment target is 120 participants. The study started on 2020-03-17. Estimated completion is 2029-06.
What conditions does trial NCT04023019 study?
This clinical trial studies the following conditions: Hemophilia A.
What interventions are being tested in trial NCT04023019?
The interventions under investigation include: Emicizumab (BIOLOGICAL), Nuwiq (BIOLOGICAL), Octanate (BIOLOGICAL), Wilate (BIOLOGICAL), Recombinant factor VIIa (rFVIIa) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04023019?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04023019 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hemophilia A
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04023019's enrollment target sits among peer trials
120 10th of 42 higher than 32 of 42 other Hemophilia A trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia A trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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