PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A）
Recruiting now · Phase 4
Conditions studied: Hemophilia, Inhibitors
In brief
This study is a multicenter, prospective, single-arm exploratory clinical trial designed to evaluate the efficacy and safety of prothrombin complex concentrate (PCC) in the treatment of bleeding episodes in patients with hemophilia A with inhibitors. All participants received on-demand PCC therapy during bleeding episodes, with dosing adjusted by investigators according to the type of bleeding. The recommended dose was 50 IU/kg per infusion, administered every 8-12 hours, with a maximum total daily dose not exceeding 150 IU/kg. If no effective hemostasis was achieved within 24 hours, investigators could decide to add other hemostatic agents or switch to alternative treatments.
Key facts
- Study ID
- NCT07406139
- Run by
- Institute of Hematology & Blood Diseases Hospital, China
- People needed
- 30
- Starts
- 2026-03-01
- Expected to finish
- 2026-12-20
- Last updated by the study team
- 2026-02-12
Who can join
Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with hemophilia A with inhibitors. For high-responding patients (those who have previously had an inhibitor titer >5 BU), the inhibitor titer at enrollment must be >0.6 BU;
- Age between 12 and 65 years;
- At least three joint bleeding episodes within the past six months;
- Signed informed consent form.
You may not qualify if…
- Presence of other congenital or acquired bleeding disorders;
- Liver function tests (ALT, AST) >2.5 times the upper limit of normal, or renal function tests (BUN, Cr) >1.5 times the upper limit of normal;
- Currently receiving immune tolerance induction (ITI) therapy with an inhibitor titer <5 BU;
- History of thrombotic events;
- Known history of drug allergy, asthma, urticaria, or other allergic conditions;
- Deemed unsuitable for study participation by the investigator.
Where it is running
- Institute of haematology and Blood diseases hospital — Tianjin, Tianjin Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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