Treatment of bleeding episodes in hemophilia patients with STSP-0601

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

This study is testing a new injection called STSP-0601 to see if it can help people with hemophilia A or B who have bleeding issues and developed inhibitors.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 12 Years to 70 Years
• Sex: All
• Sponsor: Jiangsu BioJeTay Biotechnology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Emicizumab
• Locations: 18 sites (Hefei, Anhui and 17 other locations)
• Trial ID: NCT06922045 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of STSP-0601 for injection in treating bleeding episodes in patients with hemophilia A or B who have developed inhibitors. The study involves administering multiple doses of the treatment to assess its effectiveness in managing bleeding events. Eligible participants include those aged 12 to 70 with a documented history of bleeding episodes and specific inhibitor levels. The trial aims to provide a new therapeutic option for this challenging patient population.

Who should consider this trial

Good fit: Ideal candidates are hemophilia A or B patients aged 12 to 70 with a history of bleeding episodes and elevated inhibitor titers.

Not a fit: Patients with other coagulation disorders, recent severe bleeding events, or those receiving certain anticoagulant therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of bleeding episodes in hemophilia patients with inhibitors.

How similar studies have performed: While there have been studies on treatments for hemophilia, the specific approach of using STSP-0601 in this context is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 17 other locations

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

Study contacts

• Principal investigator: Lei Zhang, Ph.D — Hospital of Hematology, Chinese Academy of Medical Sciences
• Study coordinator: Yanli Wang

Conditions Hemophilia