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Using emicizumab to prevent bleeding in patients with acquired hemophilia A

Emicizumab in Patients With Acquired Hemophilia A: Multicenter, Single-arm, Open-label Clinical Trial

Phase 2 Interventional University of Washington · NCT05345197

This study is testing if a new medicine called emicizumab can help prevent bleeding in people with acquired hemophilia A.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment51 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Washington Academic / other
Drugs / interventionsemicizumab
Locations16 sites (San Diego, California and 15 other locations)
Trial IDNCT05345197 on ClinicalTrials.gov

What this trial studies

This phase II multicenter open-label study evaluates the effectiveness of prophylactic emicizumab in preventing bleeds in patients diagnosed with acquired hemophilia A (AHA). Eligible participants will receive two initial loading doses of emicizumab followed by weekly subcutaneous doses. The primary outcome will be the assessment of bleed rates after 12 weeks of treatment, with the possibility of extending treatment for an additional 12 weeks if necessary. The study will also compare results with historical cohorts and a parallel study conducted in Germany to evaluate secondary endpoints.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of acquired hemophilia A and current bleeding episodes.

Not a fit: Patients without a diagnosis of acquired hemophilia A or those not currently experiencing bleeding episodes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce bleeding episodes in patients with acquired hemophilia A.

How similar studies have performed: Other studies have shown promise with similar approaches, indicating potential for success in this area.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Signed Informed Consent/Assent Form
* Age ≥18 years at time of signing Informed Consent Form
* Ability to comply with the study protocol, in the investigator's judgment
* Diagnosis of AHA based on a reduced FVIII activity (\<50 %) and positive FVIII inhibitor (\>0.6 BU/ml) at screening (local laboratory)
* Current bleeding due to AHA at the time of screening
* Plan to be adherent to emicizumab prophylaxis during the study
* For women of childbearing potential who meet the following criteria:
* Refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of \<1% per year during the study period A woman with ≥ 12 continuous months of amenorrhea with no identified cause other than menopause and has not undergone surgical sterilization (removal of ovaries and/or uterus). use of combined oral or injected hormonal contraceptive, bilateral tubal ligation, male sterilization, hormone- releasing intrauterine devices, and copper intrauterine devices.

Exclusion Criteria:

* Congenital hemophilia A
* 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
* Severe uncontrolled infection at the time of screening
* Signs of active disseminated intravascular coagulation at the time of screening -
* Emicizumab ⎯ AHA Emi Version 1.0 20
* Current treatment for thromboembolic disease or signs of current thromboembolic disease at time of screening
* Patients who are at high risk for TMA (e.g., have a previous medical or family history of TMA), in the investigator's judgment
* Known severe congenital or acquired thrombophilia
* Life expectancy \<3 months at the time of screening
* Other conditions that substantially increase risk of bleeding or thrombosis by the discretion of the investigator
* Contraindications according to the Investigator's Brochure of emicizumab
* Current treatment with emicizumab at time of screening
* History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection by the discretion of the investigator
* Concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose additional risk, or would, in the opinion of the local investigator, preclude the patient's safe participation in and completion of the study
* Addiction or other diseases that preclude the patient from appropriately assessing the nature and scope as well as possible consequences of the clinical study by the discretion of the investigator
* Pregnant or breast-feeding women
* Would refuse treatment with blood or blood products, if necessary.
* Subject is in custody by order of an authority or a court of law
* Treatment with any of the following:
* An investigational drug to treat or reduce the risk of hemophilic bleeds within 5 half-lives of last drug administration before Study Day 1
* A non-hemophilia-related investigational drug within the last 30 days or 5 half-lives- before Study Day 1, whichever is longer
* An investigational drug concurrently
* History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection

Where this trial is running

San Diego, California and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acquired Hemophilia AAcquire Hemophilia AemicizumabAHA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.