A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor

Phase 1

• Conditions: Hemophilia
• Interventions: Drug: STSP-0601 for Injection

• Registration Number: NCT04747964
• Lead Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-05
• Last Update Submitted: 2021-02-09
• Study First Posted: 2021-02-10
• Last Update Posted: 2021-02-12
• Primary Completion: 2021-03
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
A single lowest dose of treatment group	STSP-0601 for Injection	-
A single low dose of treatment group	STSP-0601 for Injection	-
A single low-intermediate dose of treatment group	STSP-0601 for Injection	-
A single intermediate dose of treatment group	STSP-0601 for Injection	-
A single high dose of treatment group	STSP-0601 for Injection	-
A single highest dose of treatment group	STSP-0601 for Injection	-

Primary Outcome Measures

Name	Time	Method
Number of subjects of adverse events	Baseline to Day 8
Number of subjects With Significant Abnormal Physical Examination	Baseline to Day 8
Number of subjects of Significant Abnormal Vital Signs Findings	Baseline to Day 8
Number of Participants With Significant Abnormal Laboratory Values	Baseline to Day 8
Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings	Baseline,1 hour,4 hour,48 hour,Day 8

Secondary Outcome Measures

Name	Time	Method
Activated partial thromboplastin time	Baseline to 24 hours
Thrombin production (TG) peak	Baseline to 24 hours

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, China