PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A）
A Multicenter, Prospective, Single-arm Exploratory Study of Prothrombin Complex Concentrate in the Treatment of Bleeding Episodes in Patients With Hemophilia A With Inhibitors
Institute of Hematology & Blood Diseases Hospital, China
30 participants
Mar 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria6
- 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.
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Interventions
On-demand PCC therapy during bleeding episodes. 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07406139