SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis

This study, called the SAFE Study, is looking at how well a medication called FEIBA (an activated prothrombin complex concentrate, or aPCC) works in people with Hemophilia A who are also taking Emicizumab (HEMLIBRA®) for routine bleeding prevention. Researchers want to see if a small, personalized dose of FEIBA can help stop bleeding by measuring how well your blood clots (thrombin generation). This study aims to find the right dose of FEIBA for future use during bleeding events or before surgery. You may be able to join if you are at least 6 years old, have moderately severe Hemophilia A with a high-titer inhibitor, and meet other specific criteria. The study is currently looking for 5 participants.

Study design: This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 5 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Thrombin generation capacity will be measured at baseline and up to 30 minutes after FEIBA infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis

Recruiting

PHASE3Ages 6+InterventionalTreatment

Emory University

~5 participants

Updated 2026-08-21 on ClinicalTrials.gov

What's tested:EmicizumabFEIBArFVIIa

At a glance

Recruiting sites

2 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Thrombin generation capacity after aPCC (FEIBA) infusion

Measured over Baseline and up to 30 minutes after infusion

Conditions

Hemophilia A

Where it's being run

2 sites across 1 states

Georgia2

Study leadership

Robert Sidonio, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Robert Sidonio, MD

[email protected]

404-785-1637

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Eligibility criteria

Inclusion

Moderately severe hemophilia A, defined as FVIII level \<0.05 IU/mL before development of an inhibitor

Age ≥6 years of age at time of informed consent

Documented on 2 occasions a high titer inhibitor (\>5 BU/mL) with a 72-hour washout within 2 years of enrollment

Parent/guardian (Legally Authorized Representative) or the patient has provided written informed consent

Adequate hematologic function (Hgb \>8 g/dL and platelet count \>100,000 µL)

Adequate hepatic function (total bilirubin ≤1.5 x ULN and both AST/ALT ≤3x ULN at screening (excluding known Gilbert's)

Adequate renal function (≤2.5 x ULN and CrCl ≥30 mL/min)

Exclusion

Inherited or acquired bleeding disorder other than hemophilia A excluding low VWF (\>30% VWF:RCo or VWF:GP1bm)

Had an active bleed requiring factor therapy at screening

Previous or current treatment for thromboembolic disease or signs of thromboembolic disease (excluding previously resolved line-associated thrombosis)

Had a surgical procedure 14 days before screening

Conditions that may increase the risk of bleeding or thrombosis

If the patient is treated with rFVIIa or aPCC seven days before screening

History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection

Had current use of any medication other than emicizumab that could affect the coagulation system.

Known HIV infection with CD4 count \<200 cells/µL within 24 weeks before screening. Testing is not required if \<35 years of age.

Use of systemic immunomodulators at enrollment or planned use during the study

Participants who are at high risk for TMA (for example, have a previous medical/family history of TMA), in the investigator's judgment

Concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose an additional risk, or would, in the opinion of the investigator, preclude the participant's safe participation in and completion of the study

What this trial measures

Thrombin generation capacity after aPCC (FEIBA) infusionBaseline and up to 30 minutes after infusion
Thrombin generation capacity from up to two escalating doses of aPCC will be measured using a thrombin generation assay at baseline and up to 30 minutes after FEIBA infusion.

Trialytics