Clinical trial NCT06922045: Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hemophilia
Lead sponsor: Jiangsu BioJeTay Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-10
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


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.

Primary outcomes:
measure: 12 hours effective hemostasis rate
timeFrame: 12 hours after the first administration
Secondary outcomes:
measure: Effective hemostasis rate at the first 12 hours bleeding visit
timeFrame: 12 hours after the first administration
measure: 12 hours excellent + good rate
timeFrame: 12 hours after the first administration
measure: The number of medication required for effective hemostasis within 12 hours
timeFrame: 12 hours after the first administration
measure: The amount of medication (U/kg) required for effective hemostasis within 12 hours
timeFrame: 12 hours after the first administration
measure: 8-hours effective hemostasis rate
timeFrame: 8 hours after the first administration
measure: 8-hours excellent + good rate
timeFrame: 8 hours after the first administration
measure: Complete + significant relief rate
timeFrame: 4 hours, 8 hours, 12 hours, 24 hours after the first administration
measure: The time to achieve complete/significant remission after the first administration
timeFrame: From the time after the first administration until within 72 hours after the last administration
measure: Rescue treatment rate
timeFrame: Within 72 hours after the last administration
measure: The time from the onset of bleeding to complete/significant relief
timeFrame: Within 72 hours after the last administration
measure: The effective hemostasis rate of the target joint
timeFrame: From 12 hours after the first administration to 72 hours after the last administration
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Lanzhou
country: China
facility: Lanzhou University First Hospital
state: Gansu
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Nanning
country: China
facility: The First affiliated hospital of Guangxi Medical University
state: Guangxi
city: Tangshan
country: China
facility: North China University of Science and Technology Affiliated Hospital
state: Hebei
city: Harbin
country: China
facility: Harbin First Hospital Hematology Tumor Research Center
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Jinan
country: China
facility: Jinan Central Clinical College of Shandong First Medical University
state: Shandong
city: Taiyuan
country: China
facility: Second hospital of Shanxi Medical University
state: Shanxi
city: Xi'an
country: China
facility: Xi'an Central Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences＆Sichuan Provincial People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Hospital of Hematology, Chinese Academy of Medical Sciences
state: Tianjin
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Wenzhou
country: China
facility: Wenzhou People's Hospital
state: Zhejiang
Study officials:
affiliation: Hospital of Hematology, Chinese Academy of Medical Sciences
name: Lei Zhang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: