PCC treatment for hemophilia A patients with inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, single-arm study that gives on-demand PCC to patients with hemophilia A and inhibitors during bleeding episodes. Dosing was guided by investigators with a recommended 50 IU/kg per infusion every 8–12 hours and a maximum total daily dose of 150 IU/kg. If bleeding was not controlled within 24 hours, investigators could add other hemostatic agents or switch treatments. Safety and hemostatic effectiveness were recorded across participating centers.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Mankai Ju
• Email: jumankai@ihcams.ac.cn
• Phone: +8615620988690

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.