NCT07406139RecruitingPhase 4
PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A）
A Multicenter, Prospective, Single-arm Exploratory Study of Prothrombin Complex Concentrate in the Treatment of Bleeding Episodes in Patients With Hemophilia A With Inhibitors
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 20 Nov 2025
- Start date
- 1 Mar 2026
- Primary completion date
- 20 Dec 2026
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Haemophilia
- NCT number
- NCT07406139
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 1 Mar 2026 to the primary completion date, 20 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving immune tolerance induction (ITI) therapy with an inhibitor titer \<5 BU;
Other illness
- Presence of other congenital or acquired bleeding disorders;
- History of thrombotic events;
- Known history of drug allergy, asthma, urticaria, or other allergic conditions;
Lab values
- 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;
Other
- Deemed unsuitable for study participation by the investigator.
Who the study is looking for
- 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;
- Age between 12 and 65 years;
- At least three joint bleeding episodes within the past six months;
- Signed informed consent form.
Age in the registry: 12 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of haematology and Blood diseases hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.