Back to resultsA Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
Primary Purpose
Hemophilia
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
STSP-0601 for Injection
STSP-0601 for Injection
Sponsored by
About this trial
This is an interventional treatment trial for Hemophilia
Eligibility Criteria
Inclusion Criteria:
- 18 years old ≤age≤65 years of age,male.
- Hemophilia A or B patients with inhibitors.
- Received hemostatic treatment with investigational drug (Only for group 2 of phase 2).
- Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
- Establish proper venous access.
- Agree to use adequate contraception to avoid pregnancy.
- Provide signed informed consent.
Exclusion Criteria:
- Have any coagulation disorder other than hemophilia A or B.
- Treat with prophylactic treatment of coagulation factor.
- Treat with anticoagulant within 7d of the time of study drug administration.
- Have a history of arterial and/or venous thromboembolic events.
- Have platelet <100,000/mL,hemoglobin<90g/L.
- Severe liver or kidney disease.
- Severe bleeding occurred before screening.
- Accept major operation or blood transfusion within 1 month of the time of screening.
- HIV positive with current CD4+ count of less than 200/μl.
- Have a known allergy to Blood product.
- Participate in other clinical research within 1 month of the time of study drug administration.
- Treat with coagulant within 7d of the time of study drug administration.
Sites / Locations
- Hospital of Hematology, Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Consecutive doses of low-dose of STSP-0601
Consecutive doses of high-dose of STSP-0601
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events
Proportion of successfully treated bleeding episodes
Secondary Outcome Measures
Proportion of bleeding episodes with clinical relief of signs and symptoms
Full Information
NCT ID
NCT05027230
First Posted
August 25, 2021
Last Updated
August 9, 2023
Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05027230
Brief Title
A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
Official Title
A Phase Ib/II,Multi-center, Open, Multiple-dose Design to Evaluate the Safety,Tolerability and Efficacy of STSP-0601 for Injection in Patients With Inhibitory Hemophilia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
July 15, 2023 (Actual)
Study Completion Date
July 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Consecutive doses of low-dose of STSP-0601
Arm Type
Experimental
Arm Title
Consecutive doses of high-dose of STSP-0601
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
STSP-0601 for Injection
Intervention Description
A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia
Intervention Type
Drug
Intervention Name(s)
STSP-0601 for Injection
Intervention Description
A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
From day 0 to up to day 8
Title
Proportion of successfully treated bleeding episodes
Time Frame
24 hours after administration of study drug
Secondary Outcome Measure Information:
Title
Proportion of bleeding episodes with clinical relief of signs and symptoms
Time Frame
4 hours、8 hours、24 hours after first administration of study drug
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years old ≤age≤65 years of age,male.
Hemophilia A or B patients with inhibitors.
Received hemostatic treatment with investigational drug, or to undergo minor surgical or other invasive procedures (Only for phase 2. Minor surgical procedures: procedures without general anesthesia and the wounds are easy to observe).
Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
Establish proper venous access.
Agree to use adequate contraception to avoid pregnancy.
Provide signed informed consent.
Exclusion Criteria:
Have any coagulation disorder other than hemophilia A or B.
Treat with prophylactic treatment of coagulation factor.
Treat with anticoagulant within 7d of the time of study drug administration.
Have a history of arterial and/or venous thromboembolic events.
Have platelet <100,000/mL,hemoglobin<90g/L.
Severe liver or kidney disease.
Bleeding in the central nervous system or throat before screening.
Accept major operation or blood transfusion within 1 month of the time of screening.
HIV positive with current CD4+ count of less than 200/μl.
Have a known allergy to Blood product.
Participate in other clinical research within 1 month of the time of study drug administration.
Treat with coagulant within 7d of the time of study drug administration.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Zhang, Ph.D
Organizational Affiliation
Hospital of Hematology, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Hematology, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
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