Actively Recruiting
PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A）
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-02-12
30
Participants Needed
1
Research Sites
42 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
N
North China University of Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hemophilia A with inhibitors; for high-responding patients, 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
You will not qualify if you...
- Presence of other congenital or acquired bleeding disorders
- Liver function tests (ALT, AST) >2.5 times upper limit of normal or renal function tests (BUN, Cr) >1.5 times upper limit of normal
- Currently receiving immune tolerance induction therapy with inhibitor titer <5 BU
- History of thrombotic events
- Known drug allergy, asthma, urticaria, or other allergic conditions
- Deemed unsuitable for study participation by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institute of haematology and Blood diseases hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
M
Mankai Ju
CONTACT
F
Feng Xue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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