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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form form. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

PCC

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)

Institute of haematology and Blood diseases hospital
Tianjin, Tianjin Municipality, China