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NCT05248594 · ClinicalTrials.gov registry record
Real World Use of Emicizumab in Infants and Children Ages 0-3 Years With Hemophilia A
A clinical trial, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- 71
- Enrollment target
NCT05248594: Completed study, sponsored by Montefiore Medical Center.
NCT05248594 is a clinical trial that has completed, run by Montefiore Medical Center. The registered enrollment target is 71 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05248594 has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- 71 participants
- Enrollment target
Study Summary
Hemophilia A (HA) is a rare congenital bleeding disorder characterized by coagulation factor VIII deficiency. In severe HA, defined as plasma FVIII clotting activity \< 1%, bleeding may frequently occur spontaneously, most commonly in joints, leading to painful hemophilic arthropathy and loss of joint function. Patients with moderate or mild hemophilia A, defined as FVIII clotting activity between 1-\<5% and 5-40% respectively, are less likely to have spontaneous bleeding however can have significant bleeding with trauma or surgery. Perioperative management by a hematologist who specializes in hemophilia is needed to ensure hemostasis during surgery. Hemophilia is an X-linked recessive disorder affecting 1 in 5000 to 10,000 males.
Primary Outcome
The primary outcome will include the proportion of patients that are being treated with emicizumab for primary prophylaxis, as well as identifying breakthrough bleeding while on emicizumab.
Interventions
- DRUG HEMLIBRA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2025-07-18 |
What the finished NCT05248594 record still lists
NCT05248594 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 71 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which HEMLIBRA is the first listed.
NCT05248594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05248594 about?
NCT05248594 is a clinical study titled "Real World Use of Emicizumab in Infants and Children Ages 0-3 Years With Hemophilia A". Hemophilia A (HA) is a rare congenital bleeding disorder characterized by coagulation factor VIII deficiency. In severe HA, defined as plasma FVIII clotting activity \< 1%, bleeding may frequently occur spontaneously, most commonly in joints, leading to painful hemophilic arthropathy and loss of joi...
What is the current status of trial NCT05248594?
This trial is currently completed. The enrollment target is 71 participants. The study started on 2024-08-01. Estimated completion is 2025-07-18.
What interventions are being tested in trial NCT05248594?
The interventions under investigation include: HEMLIBRA (DRUG).
Who is sponsoring clinical trial NCT05248594?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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