Back to resultsA Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
Primary Purpose
Hemophilia
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
STSP-0601 for Injection
STSP-0601 for Injection
STSP-0601 for Injection
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.
- Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
- Establish proper venous access.
- 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 an active, ongoing bleeding for which the patient is being treated, or treatment for a bleeding was stopped within 7d of the time of study drug administration.
- Have a history of arterial and/or venous thromboembolic events.
- Have platelet count <100,000/mL.
- Severe liver or kidney disease.
- Accept major operation or blood transfusion within 1 month of the time of screening.
- HIV antibody positive.
- Have a known allergy to Blood product.
- Participate in other clinical research within 1 month of the time of study drug administration.
Sites / Locations
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
A single lowest dose of treatment group
A single low dose of treatment group
A single intermediate dose of treatment group
A single high dose of treatment group
A single highest dose of treatment group
Arm Description
Outcomes
Primary Outcome Measures
Number of subjects of adverse events
Number of subjects With Significant Abnormal Physical Examination
Number of subjects of Significant Abnormal Vital Signs Findings
Number of Participants With Significant Abnormal Laboratory Values
Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings
Secondary Outcome Measures
Activated partial thromboplastin time
Thrombin production (TG) peak
Full Information
NCT ID
NCT04747964
First Posted
February 5, 2021
Last Updated
February 9, 2021
Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04747964
Brief Title
A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
Official Title
A Phase 1,Multi-center, Randomized, Open, Single-dose Escalation Design to Evaluate the Safety, Tolerability and Pharmacodynamics of STSP-0601 for Injection in Patients With Inhibitory Hemophilia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
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 pharmacokinetics and pharmacodynamics of STSP-0601 at five dose levels. The results will help identify the most optimal doses to treat bleedings in hemophilia 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
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A single lowest dose of treatment group
Arm Type
Experimental
Arm Title
A single low dose of treatment group
Arm Type
Experimental
Arm Title
A single intermediate dose of treatment group
Arm Type
Experimental
Arm Title
A single high dose of treatment group
Arm Type
Experimental
Arm Title
A single highest dose of treatment group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
STSP-0601 for Injection
Intervention Description
Subjects will receive one single lowest dose of STSP-0601 for Injection following protocol requirements
Intervention Type
Drug
Intervention Name(s)
STSP-0601 for Injection
Intervention Description
Subjects will receive one single low dose of STSP-0601 for Injection following protocol requirements
Intervention Type
Drug
Intervention Name(s)
STSP-0601 for Injection
Intervention Description
Subjects will receive one single intermediate dose of STSP-0601 for Injection following protocol requirements
Intervention Type
Drug
Intervention Name(s)
STSP-0601 for Injection
Intervention Description
Subjects will receive one single high dose of STSP-0601 for Injection following protocol requirements
Intervention Type
Drug
Intervention Name(s)
STSP-0601 for Injection
Intervention Description
Subjects will receive one single highest dose of STSP-0601 for Injection following protocol requirements
Primary Outcome Measure Information:
Title
Number of subjects of adverse events
Time Frame
Baseline to Day 8
Title
Number of subjects With Significant Abnormal Physical Examination
Time Frame
Baseline to Day 8
Title
Number of subjects of Significant Abnormal Vital Signs Findings
Time Frame
Baseline to Day 8
Title
Number of Participants With Significant Abnormal Laboratory Values
Time Frame
Baseline to Day 8
Title
Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings
Time Frame
Baseline,1 hour,4 hour,48 hour,Day 8
Secondary Outcome Measure Information:
Title
Activated partial thromboplastin time
Time Frame
Baseline to 24 hours
Title
Thrombin production (TG) peak
Time Frame
Baseline to 24 hours
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.
Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
Establish proper venous access.
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 an active, ongoing bleeding for which the patient is being treated, or treatment for a bleeding was stopped within 7d of the time of study drug administration.
Have a history of arterial and/or venous thromboembolic events.
Have platelet count <100,000/mL.
Severe liver or kidney disease.
Accept major operation or blood transfusion within 1 month of the time of screening.
HIV antibody positive.
Have a known allergy to Blood product.
Participate in other clinical research within 1 month of the time of study drug administration.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanli Wang
Phone
13811864434
Email
wangyanli@staidson.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Zhang
Organizational Affiliation
Institute of Hematology ＆ Blood Diseases Hospital，Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Zhang
Phone
+86 022 23909095
Email
ec@ihcams.ac.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
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