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Clinical Trial NCT07406139 (2022PCC-A) for Hemophilia, Inhibitors is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A） Phase 4 30

Recruiting
Clinical Trial NCT07406139 (2022PCC-A) is designed to study Treatment for Hemophilia, Inhibitors. It is a Phase 4 interventional study that is recruiting, having started on March 1, 2026, with plans to enroll 30 participants. Led by Institute of Hematology & Blood Diseases Hospital, China, it is expected to complete by December 20, 2026. The latest data from ClinicalTrials.gov was last updated on February 12, 2026.
Brief 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 w...Show More
Detailed Description
Hemophilia A is a severe and common hereditary bleeding disorder caused by a deficiency of coagulation factor VIII (FVIII). Recurrent bleeding episodes, if not treated promptly, can lead to joint deformities or pseudotumor formation and may even be life-threatening in severe cases. In recent years, with the widespread use of plasma-derived and recombinant FVIII products, the management of hemophilia A has made signif...Show More
Official Title

A Multicenter, Prospective, Single-arm Exploratory Study of Prothrombin Complex Concentrate in the Treatment of Bleeding Episodes in Patients With Hemophilia A With Inhibitors

Conditions
HemophiliaInhibitors
Other Study IDs
  • 2022PCC-A
  • IIT2022048
NCT ID Number
NCT07406139
Start Date (Actual)
2026-03-01
Last Update Posted
2026-02-12
Completion Date (Estimated)
2026-12-20
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPCC treatment
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Efficacy of prothrombin complex concentrate (PCC) in the treatment of bleeding episodes in patients with hemophilia A with inhibitors.
Hemostatic Efficacy Rate: Bleeding symptoms were evaluated at 8 hours and 24 hours after treatment. The assessment of hemostatic response included four categories: excellent, good, moderate, and ineffective.
From enrollment to the end of treatment at 24 hours
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
To evaluate the improvement score of bleeding symptoms and signs within 24 hours after the first infusion of prothrombin complex concentrate (PCC) for each bleeding episode in patients with hemophilia A with inhibitors.
From enrollment to the end of treatment at 24 hours
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
12 Years
Eligible Sexes
All
  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.

  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.
Institute of Hematology & Blood Diseases Hospital, China logoInstitute of Hematology & Blood Diseases Hospital, China
Study Central Contact
Contact: Mankai Ju, +8615620988690, [email protected]
Contact: Feng Xue, +862223608174, [email protected]
1 Study Locations in 1 Countries

Tianjin Municipality

Institute of haematology and Blood diseases hospital, Tianjin, Tianjin Municipality, 300020, China
Mankai Ju, Contact, +8615620988690, [email protected]
Lei Zhang, Contact, 2223608177, [email protected]
Recruiting