A Study of Bometase Alfa for Bleeding Control in Acquired Hemophilia A

NCT07789587 | Not Yet Recruiting

• 1 other identifier: IIT2026087
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, prospective, single-arm, exploratory study designed to evaluate the efficacy and safety of Bometase Alfa for the on-demand treatment of bleeding episodes in patients with acquired hemophilia A. A total of 20 patients with acquired hemophilia A experiencing bleeding events will be enrolled. Bometase Alfa will be administered at 0.1 U/kg for non-severe bleeding and 0.16 U/kg for severe bleeding, with consecutive doses given at 4-hour intervals until hemostasis is achieved. Treatment will be discontinued once hemostasis is achieved or if symptoms suggestive of arterial thrombosis occur, followed by a safety assessment. Rescue therapy will be initiated if bleeding remains uncontrolled after three consecutive administrations for a single bleeding episode, or if bleeding continues to worsen during treatment and the investigator determines that further treatment with Bometase Alfa is unlikely to provide clinical benefit and may pose a medical risk.

Conditions

Acquired Hemophilia A

Keywords

Acquired Hemophilia A; Bometase Alfa

Outcome Measures

Primary Outcomes (1)

• Incidence of effective hemostasis rate at 8 hours after the first administration

  8 hours

Secondary Outcomes (6)

• Incidence of effective hemostasis rate at 12 hours after the first administration

  12 hours

• Time to achieve clinical hemostasis

  30 days

• Amount of blood product use

  30 days

• Dose of Bometase Alfa administered

  30 days

• Rate of rescue therapy

  30 days

Study Arms (1)

Acquired hemophilia A receiving Bometase Alfa for bleeding control

EXPERIMENTAL

Bometase Alfa will be administered at 0.1 U/kg for non-severe bleeding or up to 0.16 U/kg for severe bleeding, with repeated doses given at 4-hour intervals until hemostasis is achieved.

Drug: Bometase Alfa

Interventions

Bometase Alfa DRUG

For non-severe bleeding, Bometase Alfa will be administered at a dose of 0.1 U/kg, while patients with severe bleeding will receive 0.16 U/kg. The study drug will be administered consecutively at 4-hour intervals until hemostasis is achieved. Treatment will be discontinued once hemostasis is achieved or if symptoms suggestive of arterial thrombosis occur, after which the patient will enter the safety assessment process.

Acquired hemophilia A receiving Bometase Alfa for bleeding control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Confirmed diagnosis of acquired hemophilia A, meeting the following criteria:
• Isolated prolongation of activated partial thromboplastin time (APTT) with a normal prothrombin time (PT);
• Reduced factor VIII coagulant activity (FVIII:C \<50%);
• 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;
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Factor 8 deficiency, acquired

Study Officials

• Lei Zhang

  Chinese Academy of Medical Science and Blood Disease Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Liu

CONTACT

+8613820261971; liuwei1@ihcams.ac.cn

Lei Zhang

CONTACT

zhanglei1@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: from 12 months to 36 months after study completion
• Access Criteria: From corresponding author

Locations

CN (1)