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

NCT05619926 | Completed Phase 2

• 1 other identifier: STSP-0601-03
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 12

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

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  From day 0 to up to day 4

• Proportion of successfully treated bleeding episodes

  8 hours after first administration of study drug

Secondary Outcomes (2)

• Proportion of successfully treated bleeding episodes

  12 hours，24 hours after first administration of study drug

• Proportion of bleeding episodes received salvage treatment

  Within 3 months after enrollment

Study Arms (2)

Consecutive doses of low-dose of STSP-0601

EXPERIMENTAL

Drug: STSP-0601 for Injection

Consecutive doses of high-dose of STSP-0601

EXPERIMENTAL

Drug: STSP-0601 for Injection

Interventions

STSP-0601 for Injection DRUG

Intravenous Injection

Consecutive doses of high-dose of STSP-0601; Consecutive doses of low-dose of STSP-0601

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤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.

You may not qualify if:

• Have any coagulation disorder other than hemophilia;
• Plan to receive prophylactic treatment of coagulation factor during the trail;
• 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.

Sponsors & Collaborators

• Staidson (Beijing) Biopharmaceuticals Co., Ltd: lead
• Beijing Novikang Medical Technology Co., LTD: collaborator

Study Sites (12)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Lanzhou University First Hospita

Lanzhou, Gansu, 730000, China

Location

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 511285, China

Location

North China University of Technology Affiliated Hospital

Tangshan, Hebei, 063000, China

Location

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, 473000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

Nanjing Gulou Hospital

Nanjing, Jiangsu, 210000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330038, China

Location

Xi'an Central Hospital

Xi’an, Shanxi, 710000, China

Location

Hospital of Hematology, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Injections

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Lei Zhang, MD

  Affiliation:Hospital of Hematology, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: January 9, 2023
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)