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Monoclonal Antibodies

Emicizumab for Hemophilia A (AHAEmi Trial)

Phase 2
Recruiting
Led By Rebecca Kruse-Jarres, MD, MPH
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years at time of signing Informed Consent Form
Current bleeding due to AHA at the time of screening
Must not have
Treatment with aPCC within the last 24 hours before first study treatment or planned treatment with aPCC during the course of the study
Known positive lupus anticoagulant at the time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 to 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a new medication can prevent bleeds in people with a rare blood disorder.

Who is the study for?
Adults diagnosed with acquired Hemophilia A, evidenced by reduced FVIII activity and positive FVIII inhibitor, can join this trial. They must be willing to adhere to emicizumab prophylaxis, not have used certain clotting treatments recently, and women of childbearing age should use effective contraception or abstain from sex.
What is being tested?
The study is testing the effectiveness of emicizumab given regularly to prevent bleeding in patients with acquired Hemophilia A. It's a phase II trial where all participants receive the same treatment without being compared to another group.
What are the potential side effects?
Emicizumab may cause injection site reactions, headaches, joint pain, and fatigue. There's also a risk for developing blood clots or an immune response that could interfere with its effectiveness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years or older.
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I am currently experiencing bleeding due to AHA.
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I have been diagnosed with AHA, with specific test results.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken aPCC in the last 24 hours and don't plan to during the study.
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I have tested positive for lupus anticoagulant.
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I do not have a severe infection that is currently uncontrolled.
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I am currently being treated with emicizumab.
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I have no health conditions that make emicizumab unsafe for me.
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I have congenital hemophilia A.
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I am currently being treated for or have signs of blood clots.
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I do not have active blood clotting disorders.
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I have a severe blood clotting disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Meassure
Secondary study objectives
Days of treatment with additional hemostatic agent
Hospitalizations
Incidence and severity of adverse events
+2 more
Other study objectives
Comparison of historic GTH-AH 01/2020 cohort/ Number of clinically significant bleeds
Hemorrhage

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental-treatmentExperimental Treatment1 Intervention
Treatment with emicizumab

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,814 Previous Clinical Trials
1,912,982 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,558 Previous Clinical Trials
569,385 Total Patients Enrolled
Rebecca Kruse-Jarres, MD, MPHPrincipal InvestigatorUniversity of Washington
4 Previous Clinical Trials
78 Total Patients Enrolled

Media Library

Emicizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05345197 — Phase 2
Acquired Hemophilia Clinical Trial 2023: Emicizumab Highlights & Side Effects. Trial Name: NCT05345197 — Phase 2
~10 spots leftby Jul 2025
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