RecruitingPhase 4NCT07406139

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


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

30 participants

Start Date

Mar 1, 2026

Study Type

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

Min Age: 12 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PCC for people with hemophilia and inhibitors. The study is currently recruiting participants at 1 location. People eligible for this study include aged 12 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPCC

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

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NCT07406139


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