Acquired Hemophilia APhase 2AHAEmiNCT05345197
Emicizumab in Patients With Acquired Hemophilia A
A Phase 2 study testing emicizumab in people with Acquired Hemophilia A, run by University of Washington at 16 sites in United States.
Trial summary
This is a phase II multicenter open-label, single-arm prospective study to evaluate the efficacy of prophylactic emicizumab administered on a scheduled basis to prevent bleeds in patients with acquired hemophilia A (AHA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Hemophilia A
- What is being tested?
- emicizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 16 sitesUnited States
- Study dates
- 31 Aug 2022to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Emory University
Atlanta, Georgia, 30308
University of Vermont Medical Center
Burlington, Vermont, 05401
University of North Carolina
Chapel Hill, North Carolina, 27514
UVA Comprehensive Cancer Center
Charlottesville, Virginia, 22908
Indiana Hemophilia and Thrombosis Center, Inc.
Indianapolis, Indiana, 46260
Versiti Inc.
Milwaukee, Wisconsin, 53226
Tulane University
New Orleans, Louisiana, 70112-2632
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Bleeding and Clotting Disorders Institute
Peoria, Illinois, 61614
Penn Blood Disorders Program, Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Hemophilia Center of Western Pennsylvania
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
UCSD Hemophilia and Thrombosis Treatment Center
San Diego, California, 92121
Washington Center for Bleeding Disorders
Seattle, Washington, 98101
Washington University
St Louis, Missouri, 63110
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: Emicizumab in Patients With Acquired Hemophilia A: Multicenter, Single-arm, Open-label Clinical Trial
This is a phase II multicenter open-label, single-arm prospective study to evaluate the efficacy of prophylactic emicizumab administered on a scheduled basis to prevent bleeds in patients with acquired hemophilia A (AHA).
Read the detailed description
Patients with AHA who are eligible will receive two loading doses of the study drug, emicizumab (6mg/kg on day 1 and 3 mg/kg on day 2) followed by once weekly subcutaneous emicizumab (1.5 mg/kg). Immunosuppression will be given concurrently as per investigator discretion. The primary endpoint (bleed rate) will be assessed after 12 weeks on study drug. If partial remission of the AHA has not been achieved, an additional 12 weeks of study drug may be given. A historical cohort and a study conducted in parallel in Germany (NCT04188639) will serve as control groups for evaluation of secondary endpoints provided the study cohort are comparable.
- Conditions
- Acquired Hemophilia A
- Being tested
- emicizumab
- Keywords
- Acquire Hemophilia A, emicizumab, AHA
- Medical subject headings
- Factor 8 deficiency, acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emicizumabDrug
Also called Hemlibra (R)
This study design uses emicizumab as a prophylaxis treatment to prevent bleeding for all participants, bypassing agents (with the exception of aPCC) and treatment of concomitant diseases will be given as clinically indicated. All eligible subjects with AHA will receive the same study medication consisting of: two loading doses of the emicizumab on day 1 and 2 followed by once weekly subcutaneous emicizumab injections. Immunosuppressive therapy (IST) will be given concurrently as per investigator discretion.
| Study group | Role | What they receive |
|---|---|---|
| Experimental-treatment | Experimental | Treatment with emicizumab Receives: Drug: emicizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Meassure
Number of clinically significant bleeds after 12 weeks of study drug (emicizumab)
Measured: 12 weeks
Secondary outcomes (5)
Incidence and severity of adverse events
Incidence and severity of adverse events, including thromboembolic events, thrombotic microangiopathy in the 12 weeks after starting emicizumab treatment; mortality and cause of death in the 24 weeks after starting emicizumab treatment.
Measured: duration of entire study
Days of treatment with additional hemostatic agent
Days of treatment with and total dose of bypassing agents (recombinant factor VIIa, activated prothrombin complex concentrate) or recombinant porcine factor VIII (susoctocag alfa) or other factor VIII concentrates; specifics (drug, amount and timing) of IST started during the 12 weeks of emicizumab prophylaxis
Measured: 12 weeks
Remission Rate
Number of patients achieving partial remission (PR) and complete remission (CR) over 12 and 24 weeks after starting emicizumab prophylaxis
Measured: 1 to 24 weeks
Hospitalizations
Days in hospital during week 12 of emicizumab treatment
Measured: 12 weeks
Total dose of additional hemostatic agent
Total dose of bypassing agents (recombinant factor VIIa, activated prothrombin complex concentrate) or recombinant porcine factor VIII (susoctocag alfa) or other factor VIII concentrates; specifics (drug, amount and timing) of IST started during the 12 weeks of emicizumab prophylaxis
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start31 Aug 2022
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Acquired Hemophilia AStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Rebecca Kruse-Jarres, University of Washington
- Investigators
- Rebecca Kruse-Jarres, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345197
- Sponsor's protocol ID
- STUDY00013920
- Acronym
- AHAEmi
- Status last verified
- Jun 2025
- First submitted
- 18 Apr 2022
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial will be shared with the research group of the parallel European study (NCT04188639). Data will be shared at the end of the study for analysis for a period of 2 years.
Publications
Franchini M, Gandini G, Di Paolantonio T, Mariani G. Acquired hemophilia A: a concise review. Am J Hematol. 2005 Sep;80(1):55-63. doi: 10.1002/ajh.20390.
PubMed 16138334Kruse-Jarres R, Kempton CL, Baudo F, Collins PW, Knoebl P, Leissinger CA, Tiede A, Kessler CM. Acquired hemophilia A: Updated review of evidence and treatment guidance. Am J Hematol. 2017 Jul;92(7):695-705. doi: 10.1002/ajh.24777. Epub 2017 Jun 5.
PubMed 28470674Kessler CM, Knobl P. Acquired haemophilia: an overview for clinical practice. Eur J Haematol. 2015 Dec;95 Suppl 81:36-44. doi: 10.1111/ejh.12689.
PubMed 26679396Tiede A, Amano K, Ma A, Arkhammar P, El Fegoun SB, Rosholm A, Seremetis S, Baudo F. The use of recombinant activated factor VII in patients with acquired haemophilia. Blood Rev. 2015 Jun;29 Suppl 1:S19-25. doi: 10.1016/S0268-960X(15)30004-7.
PubMed 26073365Sallah S. Treatment of acquired haemophilia with factor eight inhibitor bypassing activity. Haemophilia. 2004 Mar;10(2):169-73. doi: 10.1046/j.1365-2516.2003.00856.x.
PubMed 14962206Kruse-Jarres R, St-Louis J, Greist A, Shapiro A, Smith H, Chowdary P, Drebes A, Gomperts E, Bourgeois C, Mo M, Novack A, Farin H, Ewenstein B. Efficacy and safety of OBI-1, an antihaemophilic factor VIII (recombinant), porcine sequence, in subjects with acquired haemophilia A. Haemophilia. 2015 Mar;21(2):162-170. doi: 10.1111/hae.12627. Epub 2015 Jan 27.
PubMed 25623166Tiede A, Scharf RE, Dobbelstein C, Werwitzke S. Management of acquired haemophilia A. Hamostaseologie. 2015;35(4):311-8. doi: 10.5482/HAMO-14-11-0064. Epub 2015 Jan 7.
PubMed 25564260Tiede A, Klamroth R, Scharf RE, Trappe RU, Holstein K, Huth-Kuhne A, Gottstein S, Geisen U, Schenk J, Scholz U, Schilling K, Neumeister P, Miesbach W, Manner D, Greil R, von Auer C, Krause M, Leimkuhler K, Kalus U, Blumtritt JM, Werwitzke S, Budde E, Koch A, Knobl P. Prognostic factors for remission of and survival in acquired hemophilia A (AHA): results from the GTH-AH 01/2010 study. Blood. 2015 Feb 12;125(7):1091-7. doi: 10.1182/blood-2014-07-587089. Epub 2014 Dec 18.
PubMed 25525118Knoebl P, Thaler J, Jilma P, Quehenberger P, Gleixner K, Sperr WR. Emicizumab for the treatment of acquired hemophilia A. Blood. 2021 Jan 21;137(3):410-419. doi: 10.1182/blood.2020006315.
PubMed 32766881Al-Banaa K, Alhillan A, Hawa F, Mahmood R, Zaki A, El Abdallah M, Zimmerman J, Musa F. Emicizumab Use in Treatment of Acquired Hemophilia A: A Case Report. Am J Case Rep. 2019 Jul 18;20:1046-1048. doi: 10.12659/AJCR.916783.
PubMed 31318850Mohnle P, Pekrul I, Spannagl M, Sturm A, Singh D, Dechant C. Emicizumab in the Treatment of Acquired Haemophilia: A Case Report. Transfus Med Hemother. 2019 Apr;46(2):121-123. doi: 10.1159/000497287. Epub 2019 Mar 15.
PubMed 31191199Muto A, Yoshihashi K, Takeda M, Kitazawa T, Soeda T, Igawa T, Sampei Z, Kuramochi T, Sakamoto A, Haraya K, Adachi K, Kawabe Y, Nogami K, Shima M, Hattori K. Anti-factor IXa/X bispecific antibody ACE910 prevents joint bleeds in a long-term primate model of acquired hemophilia A. Blood. 2014 Nov 13;124(20):3165-71. doi: 10.1182/blood-2014-07-585737. Epub 2014 Oct 1.
PubMed 25274508Rodriguez-Merchan EC, Valentino LA. Emicizumab: Review of the literature and critical appraisal. Haemophilia. 2019 Jan;25(1):11-20. doi: 10.1111/hae.13641. Epub 2018 Nov 15.
PubMed 30431213Levy GG, Asikanius E, Kuebler P, Benchikh El Fegoun S, Esbjerg S, Seremetis S. Safety analysis of rFVIIa with emicizumab dosing in congenital hemophilia A with inhibitors: Experience from the HAVEN clinical program. J Thromb Haemost. 2019 Sep;17(9):1470-1477. doi: 10.1111/jth.14491. Epub 2019 Jun 17.
PubMed 31124272Pipe SW, Shima M, Lehle M, Shapiro A, Chebon S, Fukutake K, Key NS, Portron A, Schmitt C, Podolak-Dawidziak M, Selak Bienz N, Hermans C, Campinha-Bacote A, Kiialainen A, Peerlinck K, Levy GG, Jimenez-Yuste V. Efficacy, safety, and pharmacokinetics of emicizumab prophylaxis given every 4 weeks in people with haemophilia A (HAVEN 4): a multicentre, open-label, non-randomised phase 3 study. Lancet Haematol. 2019 Jun;6(6):e295-e305. doi: 10.1016/S2352-3026(19)30054-7. Epub 2019 Apr 16.
PubMed 31003963
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emicizumab in Patients With Acquired Hemophilia A: Multicenter, Single-arm, Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT05345197
- Acronym / sponsor ID
- AHAEmi / STUDY00013920
- Conditions
- Acquired Hemophilia A
- Keywords
- Acquire Hemophilia A, emicizumab, AHA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II multicenter open-label, single-arm prospective study to evaluate the efficacy of prophylactic emicizumab administered on a scheduled basis to prevent bleeds in patients with acquired hemophilia A (AHA).
Detailed description
Patients with AHA who are eligible will receive two loading doses of the study drug, emicizumab (6mg/kg on day 1 and 3 mg/kg on day 2) followed by once weekly subcutaneous emicizumab (1.5 mg/kg). Immunosuppression will be given concurrently as per investigator discretion. The primary endpoint (bleed rate) will be assessed after 12 weeks on study drug. If partial remission of the AHA has not been achieved, an additional 12 weeks of study drug may be given. A historical cohort and a study conducted in parallel in Germany (NCT04188639) will serve as control groups for evaluation of secondary endpoints provided the study cohort are comparable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental-treatment | Experimental | Drug: emicizumabTreatment with emicizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (24 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| emicizumabAlso: Hemlibra (R)This study design uses emicizumab as a prophylaxis treatment to prevent bleeding for all participants, bypassing agents (with the exception of aPCC) and treatment of concomitant diseases will be given as clinically indicated. All eligible subjects with AHA will receive the same study medication consisting of: two loading doses of the emicizumab on day 1 and 2 followed by once weekly subcutaneous emicizumab injections. Immunosuppressive therapy (IST) will be given concurrently as per investigator discretion. | Drug | Experimental-treatment |
Primary outcome
Primary Outcome Meassure
Time frame: 12 weeks
Number of clinically significant bleeds after 12 weeks of study drug (emicizumab)
5 secondary outcomes
Incidence and severity of adverse events
Time frame: duration of entire study
Days of treatment with additional hemostatic agent
Time frame: 12 weeks
Remission Rate
Time frame: 1 to 24 weeks
Hospitalizations
Time frame: 12 weeks
Total dose of additional hemostatic agent
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Background: PubMed 16138334Franchini M, Gandini G, Di Paolantonio T, Mariani G. Acquired hemophilia A: a concise review. Am J Hematol. 2005 Sep;80(1):55-63. doi: 10.1002/ajh.20390.
- Background: PubMed 28470674Kruse-Jarres R, Kempton CL, Baudo F, Collins PW, Knoebl P, Leissinger CA, Tiede A, Kessler CM. Acquired hemophilia A: Updated review of evidence and treatment guidance. Am J Hematol. 2017 Jul;92(7):695-705. doi: 10.1002/ajh.24777. Epub 2017 Jun 5.
- Background: PubMed 26679396Kessler CM, Knobl P. Acquired haemophilia: an overview for clinical practice. Eur J Haematol. 2015 Dec;95 Suppl 81:36-44. doi: 10.1111/ejh.12689.
- Background: PubMed 26073365Tiede A, Amano K, Ma A, Arkhammar P, El Fegoun SB, Rosholm A, Seremetis S, Baudo F. The use of recombinant activated factor VII in patients with acquired haemophilia. Blood Rev. 2015 Jun;29 Suppl 1:S19-25. doi: 10.1016/S0268-960X(15)30004-7.
- Background: PubMed 14962206Sallah S. Treatment of acquired haemophilia with factor eight inhibitor bypassing activity. Haemophilia. 2004 Mar;10(2):169-73. doi: 10.1046/j.1365-2516.2003.00856.x.
- Background: PubMed 25623166Kruse-Jarres R, St-Louis J, Greist A, Shapiro A, Smith H, Chowdary P, Drebes A, Gomperts E, Bourgeois C, Mo M, Novack A, Farin H, Ewenstein B. Efficacy and safety of OBI-1, an antihaemophilic factor VIII (recombinant), porcine sequence, in subjects with acquired haemophilia A. Haemophilia. 2015 Mar;21(2):162-170. doi: 10.1111/hae.12627. Epub 2015 Jan 27.
- Background: PubMed 25564260Tiede A, Scharf RE, Dobbelstein C, Werwitzke S. Management of acquired haemophilia A. Hamostaseologie. 2015;35(4):311-8. doi: 10.5482/HAMO-14-11-0064. Epub 2015 Jan 7.
- Background: PubMed 25525118Tiede A, Klamroth R, Scharf RE, Trappe RU, Holstein K, Huth-Kuhne A, Gottstein S, Geisen U, Schenk J, Scholz U, Schilling K, Neumeister P, Miesbach W, Manner D, Greil R, von Auer C, Krause M, Leimkuhler K, Kalus U, Blumtritt JM, Werwitzke S, Budde E, Koch A, Knobl P. Prognostic factors for remission of and survival in acquired hemophilia A (AHA): results from the GTH-AH 01/2010 study. Blood. 2015 Feb 12;125(7):1091-7. doi: 10.1182/blood-2014-07-587089. Epub 2014 Dec 18.
- Background: PubMed 32766881Knoebl P, Thaler J, Jilma P, Quehenberger P, Gleixner K, Sperr WR. Emicizumab for the treatment of acquired hemophilia A. Blood. 2021 Jan 21;137(3):410-419. doi: 10.1182/blood.2020006315.
- Background: PubMed 31318850Al-Banaa K, Alhillan A, Hawa F, Mahmood R, Zaki A, El Abdallah M, Zimmerman J, Musa F. Emicizumab Use in Treatment of Acquired Hemophilia A: A Case Report. Am J Case Rep. 2019 Jul 18;20:1046-1048. doi: 10.12659/AJCR.916783.
- Background: PubMed 31191199Mohnle P, Pekrul I, Spannagl M, Sturm A, Singh D, Dechant C. Emicizumab in the Treatment of Acquired Haemophilia: A Case Report. Transfus Med Hemother. 2019 Apr;46(2):121-123. doi: 10.1159/000497287. Epub 2019 Mar 15.
- Background: PubMed 25274508Muto A, Yoshihashi K, Takeda M, Kitazawa T, Soeda T, Igawa T, Sampei Z, Kuramochi T, Sakamoto A, Haraya K, Adachi K, Kawabe Y, Nogami K, Shima M, Hattori K. Anti-factor IXa/X bispecific antibody ACE910 prevents joint bleeds in a long-term primate model of acquired hemophilia A. Blood. 2014 Nov 13;124(20):3165-71. doi: 10.1182/blood-2014-07-585737. Epub 2014 Oct 1.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial will be shared with the research group of the parallel European study (NCT04188639). Data will be shared at the end of the study for analysis for a period of 2 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Kruse-Jarres, MD, MPH principal investigator
University of Washington
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing emicizumab in people with Acquired Hemophilia A, run by University of Washington at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Meassure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05345197, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.