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A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia A

StatusActive, Not Recruiting
PhasePhase 3
Started2024-11-12
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 12, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-06-11
Not Yet Recruiting→Active, Not Recruiting Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Active, Not Recruiting
Primary completion date2025-04→2026-07
Completion date2025-04→2026-07
Start dateestimated 2024-04→confirmed 2024-11-12
Study sites11→12
Eligibility criteria-42 characters
[...] igned an informed consent form, and had good compliance; Age: ≥ 12 years old and ≤ 65 years old (whencalculated from the date of signing the informed consent form,): if≥12 ityears isand a≤65 minor, parents should sign on behalf of it)years; Severe hemophilia A (coagulation factor VIII activity<1%), [...]
Secondary endpoints7 to 13 entries
The incidence of recombinant human coagulation factor VIII inhibitors Incremental recovery in non-bleeding state The incidence of adverse events was assessed by vital signs The incidence of adverse events was assessed by physical examination The incidence of adverse events was assessed by electrocar [...]
2024-03-01
Original filing
This study is a single arm, open, multicenter clinical trial in which the previous treated severe hemophilia A patients receive recombinant human coagulation factor VIII for injection to evaluate the efficacy and safety of on-demand treatment in the event of new bleeding events. If evaluable surgical cases occur, the overall efficacy and safety of recombinant human coagulation factor VIII for injection as a replacement therapy for severe hemophilia A PTPs during the perioperative period will be evaluated.
Trial Details
NCT Number NCT06297655
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Conditions Hemophilia A
Enrollment 60 participants
Start Date 2024-11-12
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-12