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A Clinical Investigation of the Efficacy and Safety of Immune Tolerance Induction (ITI) in Conjunction with Immuno-Suppressive Therapy (IST) for the Management of Hemophilia A Patients with Inhibitors

A Clinical Investigation of the Efficacy and Safety of Immune Tolerance Induction (ITI) in Conjunction with Immuno-Suppressive Therapy (IST) for the Management of Hemophilia A Patients with Inhibitors

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097092
Enrollment
Unknown
Registered
2025-02-12
Start date
2023-11-10
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Interventions

Repatumab group:Repertumab was administered intravenously.
Repatumab + bortezomib group:Intravenous administration of repatumab in conjunction with subcutaneous injection of bortezomib

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. There is no evidence of a bleeding tendency. 2. The patient has a prior diagnosis of hemophilia A and a history of coagulation factor VIII infusions. 3. Laboratory findings indicate prolonged APTT, whereas PT, TT, Fib, PLT, von Willebrand factor antigen (VWF:Ag), and VWF activity (VWF:Act) remain within normal limits. 4. Factor VIII activity (FVIII:C) is less than 5%. 5. The Bethesda assay confirmed the presence of FVIII inhibitors with a titer exceeding 0.6 BU/ml.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with acquired hemophilia A; 2. Hemophilia A patients with inhibitors who present with life-threatening non-hematological conditions; 3. Patients with uncontrolled infections, active hepatitis, or severe immunodeficiency diseases such as AIDS; 4. Patients known to be allergic to any CD20 monoclonal antibody, murine proteins, or any excipient in repatol.

Design outcomes

Primary

MeasureTime frame
Coagulation factor ? activity;Coagulation factor ? inhibitor titer;

Secondary

MeasureTime frame
monthly bleeding rate;

Countries

China

Contacts

Public ContactJing-yu Zhang

The Second Hospital of Hebei Medical University

zhangjy69@163.com+86 180 3222 7288

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026