drugset / Trial / NCT07406139
PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A）
Phase 4
Recruiting
30 enrolled
Institute of Hematology & Blood Diseases Hospital, China
Children's Hospital of Chongqing Medical University · collabFirst Affiliated Hospital of Guangxi Medical University · collabNorth China University of Science and Technology · collabThe First Affiliated Hospital of Xiamen University · collabThe Second Affiliated Hospital of Kunming Medical University · collabThe Second People's Hospital of Anhui Province · collabUnion Hospital, Affiliated to Fujian Medical University · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-03-01
- Primary completion
- 2026-12-20
- Completion
- 2026-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prothrombin Complex Concentrate | Protein / enzyme biologic | 50 iu/kg | — |