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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients

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 III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients (NCT06922045) is a Phase 3 interventional studying Hemophilia, sponsored by Jiangsu BioJeTay Biotechnology Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Hemophilia, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. 12 ≤age≤70 years of age. 2. Hemophilia A or B patients. 3. Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled. 4. Establish proper venous access. 5. There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening. 6. Agree to use adequate contraception to avoid pregnancy. 7. Provide signed willing to sign a consent form. Who Should NOT Join This Trial: 1. Have any coagulation disorder other than hemophilia. 2. Plan to receive prophylactic treatment of coagulation factor during the trail. 3. Patients plan to receive Emicizumab during the trial. 4. Patients received anticoagulant or antifibrinolytic therapy 7 days before the first administration or plan to receive these drugs during the trial. 5. Have a history of arterial and/or venous thrombotic events. 6. Platelet \<100×109/L. 7. Hemoglobin\<90g/L. 8. Severe liver or kidney disease. 9. Severe bleeding event occurred within 4 weeks before the first administration. 10. Accepted major operation or blood transfusion within 4 weeks before the first administration. 11. Have a known allergy to STSP-0601. 12. Pregnant, lactating, or blood pregnancy test positive female subjects 13. Participate in other clinical research within 4 weeks before enrollment (except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails). 14. Within 1 day before the first administration, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days before the first administration, prothrombin complex, FVIII, and FIX were used. Within 4 weeks, treatment with Emicizumab was received. 15. Patients not suitable for the trail according to the judgment of the investigators. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 12 ≤age≤70 years of age. 2. Hemophilia A or B patients. 3. Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled. 4. Establish proper venous access. 5. There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening. 6. Agree to use adequate contraception to avoid pregnancy. 7. Provide signed informed consent. Exclusion Criteria: 1. Have any coagulation disorder other than hemophilia. 2. Plan to receive prophylactic treatment of coagulation factor during the trail. 3. Patients plan to receive Emicizumab during the trial. 4. Patients received anticoagulant or antifibrinolytic therapy 7 days before the first administration or plan to receive these drugs during the trial. 5. Have a history of arterial and/or venous thrombotic events. 6. Platelet \<100×109/L. 7. Hemoglobin\<90g/L. 8. Severe liver or kidney disease. 9. Severe bleeding event occurred within 4 weeks before the first administration. 10. Accepted major operation or blood transfusion within 4 weeks before the first administration. 11. Have a known allergy to STSP-0601. 12. Pregnant, lactating, or blood pregnancy test positive female subjects 13. Participate in other clinical research within 4 weeks before enrollment (except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails). 14. Within 1 day before the first administration, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days before the first administration, prothrombin complex, FVIII, and FIX were used. Within 4 weeks, treatment with Emicizumab was received. 15. Patients not suitable for the trail according to the judgment of the investigators.

Treatments Being Tested

DRUG

STSP-0601 for Injection

Evaluation of the Efficacy of Single-Dose and Continuous Administration of STSP-0601 Injection for the Treatment of Bleeding in Patients with Hemophilia A or B with Inhibitors

Locations (18)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Anhui Provincial Hospital
Hefei, Anhui, China
Lanzhou University First Hospital
Lanzhou, Gansu, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
The First affiliated hospital of Guangxi Medical University
Nanning, Guangxi, China
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China
Harbin First Hospital Hematology Tumor Research Center
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Huazhong University of Science and Technology Union Hospital
Wuhan, Hubei, China
Jiangsu Provincial Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jinan Central Clinical College of Shandong First Medical University
Jinan, Shandong, China
Second hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Xi'an Central Hospital
Xi’an, Shanxi, China
Sichuan Academy of Medical Sciences＆Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Wenzhou People's Hospital
Wenzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06922045), the sponsor (Jiangsu BioJeTay Biotechnology Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06922045 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06922045?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06922045?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06922045. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06922045. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.