PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A）
Recruiting
Phase 4
Interventional Study
Hemophilia
Inhibitors
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 – 65
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China · Other
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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. Th…
Trial Locations
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Eligibility Criteria
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 s…
Contacts