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

Hemophilia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04747964
• Other study ID #: STSP-0601-01
• Status: Recruiting
• Phase: Phase 1
• Start date: January 15, 2020
• Est. completion date: May 2021

Study information

• Verified date: February 2021
• Source: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Contact: Yanli Wang
• Phone: 13811864434
• Email: wangyanli[@]staidson.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: May 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

Intervention

Drug:
• STSP-0601 for Injection
Subjects will receive one single lowest dose of STSP-0601 for Injection following protocol requirements
• STSP-0601 for Injection
Subjects will receive one single low dose of STSP-0601 for Injection following protocol requirements
• STSP-0601 for Injection
Subjects will receive one single intermediate dose of STSP-0601 for Injection following protocol requirements
• STSP-0601 for Injection
Subjects will receive one single high dose of STSP-0601 for Injection following protocol requirements
• STSP-0601 for Injection
Subjects will receive one single highest dose of STSP-0601 for Injection following protocol requirements

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Staidson (Beijing) Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects of adverse events		Baseline to Day 8
Primary	Number of subjects With Significant Abnormal Physical Examination		Baseline to Day 8
Primary	Number of subjects of Significant Abnormal Vital Signs Findings		Baseline to Day 8
Primary	Number of Participants With Significant Abnormal Laboratory Values		Baseline to Day 8
Primary	Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings		Baseline,1 hour,4 hour,48 hour,Day 8
Secondary	Activated partial thromboplastin time		Baseline to 24 hours
Secondary	Thrombin production (TG) peak		Baseline to 24 hours