Can a new drug stop bleeding in acquired hemophilia a?
NCT ID NCT07789587
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This trial tests whether an experimental drug called bometase alfa can safely stop bleeding episodes in people with acquired hemophilia A, a rare condition where the immune system attacks a key blood-clotting protein. About 20 adults with active bleeding will receive the drug by injection every 4 hours until bleeding stops, with a higher dose for severe bleeding. Researchers will measure how quickly bleeding stops and watch for side effects, including signs of artery-blocking clots. The study is exploratory, so it aims to gather early evidence on whether the drug works and is safe enough for further testing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bometase alfa, an experimental drug given by injection to control bleeding episodes
- What this could lead to
- If it works, bometase alfa could offer a new on-demand option to stop bleeding in people with acquired hemophilia A, potentially reducing the need for blood products and rescue therapies.
- What could go wrong
- This is a small, early exploratory study with only 20 participants, so results may not apply broadly. The drug carries a risk of arterial thrombosis, and bleeding may not be controlled in all cases.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years; * Confirmed diagnosis of acquired hemophilia A, meeting the following criteria: 1. Isolated prolongation of activated partial thromboplastin time (APTT) with a normal prothrombin time (PT); 2. Reduced factor VIII coagulant activity (FVIII:C \<50%); 3. Positive FVIII inhibitor, defined as ≥0.6 BU/mL as measured by the Bethesda assay or Nijmegen-modified Bethesda assay, or failure of a 1:1 mixing study with normal plasma to achieve complete correction; 4. No evidence of congenital hemophilia, von Willebrand disease, or lupus anticoagulant; * Presence of clinically significant active bleeding, including, but not limited to, muscle or subcutaneous hematoma, gastrointestinal or genitourinary bleeding, postpartum or postoperative bleeding, or deep-seated or life-threatening organ bleeding; * Provision of written informed consent by the patient and/or a legally authorized representative; * Ability to comply with the study follow-up schedule for at least 30 da Exclusion Criteria: * Congenital hemophilia A or B, or any other confirmed congenital coagulation factor deficiency; * Isolated prolonged activated partial thromboplastin time (APTT) due to lupus anticoagulant or antiphospholipid syndrome, with a negative FVIII inhibitor and normal FVIII activity; or coagulation abnormalities caused by disseminated intravascular coagulation (DIC) or severe liver disease that do not fulfill the diagnostic criteria for acquired hemophilia A; * A history or symptoms of any arterial or venous thromboembolic event within 3 months before enrollment, including atherosclerosis, myocardial infarction, ischemic stroke, transient ischemic attack, deep vein thrombosis, or pulmonary embolism, or the presence of DIC; * Use of factor VII (FVII), activated factor VII (FVIIa), tranexamic acid, or aminocaproic acid within 1 day before the planned administration of the study drug; or use of prothrombin complex concentrate (PCC) or factor VIII (FVIII) within 3 days before the first administration; * Female participants who are pregnant or breastfeeding, or have a positive pregnancy test; * Known hypersensitivity to the investigational product or any of its excipients; * Inability to obtain informed consent, including patients unable to express their wishes and without a legally authorized representative; * Inability to comply with the study follow-up requirements or investigator-determined poor compliance; * Any other condition for which the investigator considers the participant unsuitable for study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, China
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