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Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor

Primary Purpose

Hemophilia

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
STSP-0601 for Injection
Sponsored by
Staidson (Beijing) Biopharmaceuticals Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 18 ≤age≤70 years of age,male; Hemophilia A or B patients; A bleeding event requiring treatment occurred (Only applicable to the on-demand treatment stage); Factor VIII or IX level <2%, inhibitor titer < 0.6 BU; There were at least 2 bleeding events that requiring treatment occurred in the past 6 months before screening (Only the second stage is applicable); 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; Plan to receive prophylactic treatment of coagulation factor during the trail; 4 weeks before screening, receive prophylactic treatment of amesetuzumab or plan to receive prophylactic treatment of amesetuzumab during the trial; Patients received anticoagulant or antifibrinolytic therapy 7 days before enrollment or plan to receive these drugs during the trial; Patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment; Have a history of arterial and/or venous thrombotic events; Platelet <100×109/L; Hemoglobin<90g/L; Severe liver or kidney disease; Severe bleeding event occurred within 4 weeks before enrollment; Accepted major operation or blood transfusion within 4 weeks before enrollment; HIV positive; Have a known allergy to STSP-0601; Participate in other clinical research within 4 weeks before enrollment(except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails); Patients not suitable for the trail according to the judgment of the investigators.

Sites / Locations

  • Hospital of Hematology, Chinese Academy of Medical SciencesRecruiting

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 successfully treated bleeding episodes
Proportion of bleeding episodes received salvage treatment

Full Information

First Posted
November 9, 2022
Last Updated
January 18, 2023
Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Collaborators
Beijing Novikang Medical Technology Co., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT05619926
Brief Title
Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor
Official Title
A Multi-center, Open-label, Multiple-dose Design, Phase 2 Trial to Evaluate the Safety and Efficacy of STSP-0601 for Injection in Patients With Hemophilia Without Inhibitor
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Collaborators
Beijing Novikang Medical Technology 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,efficacy,pharmacokinetics and pharmacodynamics of multiple-dose of STSP-0601 at two dose levels for the treatment of bleeding episodes in hemophilia A or B patients without inhibitor.

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 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

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
Intravenous Injection
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
From day 0 to up to day 4
Title
Proportion of successfully treated bleeding episodes
Time Frame
8 hours after first administration of study drug
Secondary Outcome Measure Information:
Title
Proportion of successfully treated bleeding episodes
Time Frame
12 hours,24 hours after first administration of study drug
Title
Proportion of bleeding episodes received salvage treatment
Time Frame
Within 3 months after enrollment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 ≤age≤70 years of age,male; Hemophilia A or B patients; A bleeding event requiring treatment occurred (Only applicable to the on-demand treatment stage); Factor VIII or IX level <2%, inhibitor titer < 0.6 BU; There were at least 2 bleeding events that requiring treatment occurred in the past 6 months before screening (Only the second stage is applicable); 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; Plan to receive prophylactic treatment of coagulation factor during the trail; 4 weeks before screening, receive prophylactic treatment of amesetuzumab or plan to receive prophylactic treatment of amesetuzumab during the trial; Patients received anticoagulant or antifibrinolytic therapy 7 days before enrollment or plan to receive these drugs during the trial; Patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment; Have a history of arterial and/or venous thrombotic events; Platelet <100×109/L; Hemoglobin<90g/L; Severe liver or kidney disease; Severe bleeding event occurred within 4 weeks before enrollment; Accepted major operation or blood transfusion within 4 weeks before enrollment; HIV positive; Have a known allergy to STSP-0601; Participate in other clinical research within 4 weeks before enrollment(except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails); Patients not suitable for the trail according to the judgment of the investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanli Wang
Phone
010-67519614
Email
wangyanli@staidson.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Zhang, MD
Organizational Affiliation
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Zhang
Phone
022-23909095
Email
zhanglei1@ihcams.ac.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor

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