Last reviewed · How we verify
NCT06922045
A Phase III Clinical Study on the Efficacy and Safety of STSP-0601 for Injection in Patients With Hemophilia Associated With Inhibitors, With a Multicenter, Open Evaluation Approach
Phase 3 trial testing STSP-0601 for Injection in Hemophilia in 40 participants. Currently enrolling.
1 September 2026
Quick facts
| Lead sponsor | Jiangsu BioJeTay Biotechnology Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 26 March 2025 |
| Primary completion | 1 September 2026 |
| Estimated completion | 1 March 2027 |
| Sites | 18 locations across China |
Drugs / interventions tested
- STSP-0601 for Injection — full drug profile →
Conditions studied
- Hemophilia — all drugs for Hemophilia →
Sponsor
Jiangsu BioJeTay Biotechnology Co., Ltd. — full company profile →
Who can join
Adults 12 to 70, any sex, with Hemophilia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
12 hours effective hemostasis rate
Time frame: 12 hours after the first administration
Sponsor's own description
This study will assess the efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A specific FX activator for bleeding treatment in hemophilia with inhibitors: multicenter, open-label, phase 1/2 trials.
Liu W, Zhou H, Huang R, Du X, et al · · 2026 · PMID 41637644 · DOI 10.1182/bloodadvances.2025019486
Verify or expand the search:
- PubMed search for NCT06922045
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of STSP-0601 for Injection
Trials testing the same drug.
- NCT06289166 — Safety and Efficacy of STSP-0601 in Adult Patients with Hemophilia a or B with Inhibitor · Phase 2 · completed
- NCT05619926 — Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor · Phase 2 · completed
- NCT05027230 — A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor · Phase 1, PHASE2 · completed
- NCT04747964 — A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor · Phase 1 · completed
Other recruiting trials for Hemophilia
Currently open trials in the same condition.
- NCT07579585 — Effects of Photobiomodulation in Hemophilia Patients. · NA · recruiting
- NCT07406139 — PCC Treatment for Hemophilia Patients With Inhibitor(2022PCC-A) · Phase 4 · recruiting
- NCT07285460 — A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Year · Phase 3 · recruiting
- NCT07187661 — Intra-Articular Bevacizumab for Preventing Recurrent Hemarthrosis in Hemophilia With Chronic Synovitis · NA · recruiting
- NCT07099313 — Association of Prophylactic Treatment With Treatment Burden and Psychosocial Variables in Patients With Hemophilia · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06922045 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu BioJeTay Biotechnology Co., Ltd.
- Last refreshed: 22 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06922045.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing