Completed
A Phase Ib/II,Multi-center, Open, Multiple-dose Design to Evaluate the Safety,Tolerability and Efficacy of STSP-0601 for Injection in Patients With Inhibitory Hemophilia
What is being tested
STSP-0601 for Injection
Drug
Who is being recruted
Blood Coagulation Disorders+6
+ Hematologic Diseases
+ Hemic and Lymphatic Diseases
From 18 to 65 Years
+19 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1 & 2
Interventional
Study Start: October 2021
Summary
Principal SponsorStaidson (Beijing) Biopharmaceuticals Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 12, 2021
Actual date on which the first participant was enrolled.This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors.
Official TitleA Phase Ib/II,Multi-center, Open, Multiple-dose Design to Evaluate the Safety,Tolerability and Efficacy of STSP-0601 for Injection in Patients With Inhibitory Hemophilia
Principal SponsorStaidson (Beijing) Biopharmaceuticals Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
77 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Male
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemophilia AHemorrhagic DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCoagulation Protein DisordersBlood Coagulation Disorders, InheritedGenetic Diseases, Inborn
Criteria
7 inclusion criteria required to participate
18 years old ≤age≤65 years of age,male.
Hemophilia A or B patients with inhibitors.
Received hemostatic treatment with investigational drug, or to undergo minor surgical or other invasive procedures (Only for phase 2. Minor surgical procedures: procedures without general anesthesia and the wounds are easy to observe).
Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
Show More Criteria
12 exclusion criteria prevent from participating
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 a history of arterial and/or venous thromboembolic events.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, ChinaOpen Hospital of Hematology, Chinese Academy of Medical Sciences in Google MapsCompletedOne Study Center