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NCT04205175 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Safest Dose Range for FEIBA in Hemophilia A Patients With Inhibitors on Emicizumab
A Phase 4 study of Hemophilia A With Inhibitor, sponsored by Children's Hospital Los Angeles.
- Active
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04205175 is a Phase 4 study of Hemophilia A With Inhibitor that is active but no longer recruiting, run by Children's Hospital Los Angeles. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04205175, a Phase 4 study of Hemophilia A With Inhibitor, is active but no longer recruiting, sponsored by Children's Hospital Los Angeles.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Hemophilia A is a severe, life-long, genetic bleeding disorder characterized by a deficiency of factor VIII (FVIII), a crucial cofactor of the coagulation system. The mainstay of hemophilia treatment is factor replacement therapy with FVIII clotting factor concentrates (CFC) and these can be given episodically in response to bleeding or prophylactically to prevent bleeding. The main adverse effect of FVIII CFC is the development of neutralizing anti-drug antibodies termed inhibitors, and these render replacement therapy less effective if they are low titer inhibitors or completely ineffective if they are of the high titer variety. These so-called 'inhibitor patients' cannot rely on FVIII CFC for their treatment and are treated with other CFC called bypassing agents such as activated prothrombin complex concentrate (aPCC/Feiba). While these agents can be effective in some patients for prophylaxis, they are not as effective for bleed prevention as FVIII CFC for patients without inhibitors.Recently, emicizumab (Hemlibra, Roche), was developed and licensed for the prevention of bleeding in patients with hemophilia A with and without inhibitors. However, patients in the clinical trials for emicizumab have developed thrombotic adverse events and only patients who received doses of Feiba of \>100 IU/kg/24 hours for more than 24 hours developed thrombosis. As a result of the above data, recommendations have been to either avoid altogether in patients on emicizumab, or to be very cautious about using it to treat breakthrough bleeding. With this in mind, we propose to study the in vivo combination of Feiba in patients with inhibitors on emicizumab.
Conditions Studied
Interventions
- DRUG Feiba
Study Locations (1)
California
- Childrens Hospital Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2022-10 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04205175
The ClinicalTrials.gov registry entry for NCT04205175 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hemophilia A With Inhibitor appearing as the primary indexed condition, and to 1 intervention - of which Feiba is the first listed.
NCT04205175 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04205175 about?
NCT04205175 is a clinical study titled "A Study to Evaluate the Safest Dose Range for FEIBA in Hemophilia A Patients With Inhibitors on Emicizumab". Hemophilia A is a severe, life-long, genetic bleeding disorder characterized by a deficiency of factor VIII (FVIII), a crucial cofactor of the coagulation system. The mainstay of hemophilia treatment is factor replacement therapy with FVIII clotting factor concentrates (CFC) and these can be given e...
What is the current status of trial NCT04205175?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2020-07-01. Estimated completion is 2022-10.
What conditions does trial NCT04205175 study?
This clinical trial studies the following conditions: Hemophilia A With Inhibitor.
What interventions are being tested in trial NCT04205175?
The interventions under investigation include: Feiba (DRUG).
Who is sponsoring clinical trial NCT04205175?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04205175 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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