PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A） (NCT07406139) | Clinical Trial Compass
RecruitingPhase 4
PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A）
China30 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range12 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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;
What they're measuring
1
Efficacy of prothrombin complex concentrate (PCC) in the treatment of bleeding episodes in patients with hemophilia A with inhibitors.
Timeframe: From enrollment to the end of treatment at 24 hours
Trial details
NCT IDNCT07406139
SponsorInstitute of Hematology & Blood Diseases Hospital, China