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

NCT ID: NCT05619926

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2023-08-25

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.

Conditions

Hemophilia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Consecutive doses of low-dose of STSP-0601

Group Type: EXPERIMENTAL

STSP-0601 for Injection

Intervention Type: DRUG

Intravenous Injection

Consecutive doses of high-dose of STSP-0601

Group Type: EXPERIMENTAL

STSP-0601 for Injection

Intervention Type: DRUG

Intravenous Injection

Interventions

STSP-0601 for Injection

Intravenous Injection

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Novikang Medical Technology Co., LTD

UNKNOWN

Sponsor Role: collaborator

Staidson (Beijing) Biopharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lei Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Affiliation:Hospital of Hematology, Chinese Academy of Medical Sciences

Locations

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Lanzhou University First Hospita

Lanzhou, Gansu, China

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

North China University of Technology Affiliated Hospital

Tangshan, Hebei, China

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Nanjing Gulou Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Xi'an Central Hospital

Xi’an, Shanxi, China

Hospital of Hematology, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Countries

China

Other Identifiers

STSP-0601-03

Identifier Type: -

Identifier Source: org_study_id