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PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A）

RecruitingPhase 4Ages 12 Years - 65 YearsAllInstitute of Hematology & Blood Diseases Hospital…
NCT07406139 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 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; 2. Age between 12 and 65 years; 3. At least three joint bleeding episodes within the past six months; 4. Signed informed consent form. Exclusion Criteria: 1. Presence of other congenital or acquired bleeding disorders; 2. 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; 3. Currently receiving immune tolerance induction (ITI) therapy with an inhibitor titer \<5 BU; 4. History of thrombotic events; 5. Known history of drug allergy, asthma, urticaria, or other allergic conditions; 6. Deemed unsuitable for study participation by the investigator.
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What it tests

  • PCC
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Where

1 site
Institute of haematology and Blood diseases hospital
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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