NCT07406139 PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A）
| NCT ID | NCT07406139 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Hemophilia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2026-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2026-03-01 with a primary completion date of 2026-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07406139 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 65 Years, studying Hemophilia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07406139 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07406139 currently recruiting?
Yes, NCT07406139 is actively recruiting participants. Contact the research team at jumankai@ihcams.ac.cn for enrollment information.
Where is the NCT07406139 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07406139 clinical trial?
NCT07406139 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 30 participants.