Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients

April 22, 2026 updated by: Jiangsu BioJeTay Biotechnology Co., Ltd.

A Phase III Clinical Study on the Efficacy and Safety of STSP-0601 for Injection in Patients With Hemophilia Associated With Inhibitors, With a Multicenter, Open Evaluation Approach

This study will assess the efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Not yet recruiting
        • Anhui Provincial Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • Lanzhou University First Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • Shenzhen Second People's Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Hebei
      • Tangshan, Hebei, China, 063000
        • Recruiting
        • North China University of Science and Technology Affiliated Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Recruiting
        • Harbin First Hospital Hematology Tumor Research Center
        • Contact:
          • Jun Ma
          • Phone Number: 0451-84883471
    • Henan
      • Zhengzhou, Henan, China, 300020
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Huazhong University of Science and Technology Union Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Provincial Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Jinan Central Clinical College of Shandong First Medical University
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Not yet recruiting
        • Second Hospital of Shanxi Medical University
        • Contact:
      • Xi’an, Shanxi, China, 710000
        • Recruiting
        • Xi'an Central Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Not yet recruiting
        • Sichuan Academy of Medical Sciences＆Sichuan Provincial People's Hospital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Recruiting
        • Hospital of Hematology, Chinese Academy of Medical Sciences
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Recruiting
        • The Second Affiliated Hospital of Kunming Medical University
        • Contact:
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • Wenzhou People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 12 ≤age≤70 years of age.
  2. Hemophilia A or B patients.
  3. Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
  4. Establish proper venous access.
  5. There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening.
  6. Agree to use adequate contraception to avoid pregnancy.
  7. Provide signed informed consent.

Exclusion Criteria:

  1. Have any coagulation disorder other than hemophilia.
  2. Plan to receive prophylactic treatment of coagulation factor during the trail.
  3. Patients plan to receive Emicizumab during the trial.
  4. Patients received anticoagulant or antifibrinolytic therapy 7 days before the first administration or plan to receive these drugs during the trial.
  5. Have a history of arterial and/or venous thrombotic events.
  6. Platelet <100×109/L.
  7. Hemoglobin<90g/L.
  8. Severe liver or kidney disease.
  9. Severe bleeding event occurred within 4 weeks before the first administration.
  10. Accepted major operation or blood transfusion within 4 weeks before the first administration.
  11. Have a known allergy to STSP-0601.
  12. Pregnant, lactating, or blood pregnancy test positive female subjects
  13. Participate in other clinical research within 4 weeks before enrollment (except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).
  14. Within 1 day before the first administration, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days before the first administration, prothrombin complex, FVIII, and FIX were used. Within 4 weeks, treatment with Emicizumab was received.
  15. Patients not suitable for the trail according to the judgment of the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous administration of STSP-0601
Drug: STSP-0601 for Injection
Evaluation of the Efficacy of Single-Dose and Continuous Administration of STSP-0601 Injection for the Treatment of Bleeding in Patients with Hemophilia A or B with Inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
12 hours effective hemostasis rate
Time Frame: 12 hours after the first administration
12 hours after the first administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Effective hemostasis rate at the first 12 hours bleeding visit
Time Frame: 12 hours after the first administration
12 hours after the first administration
12 hours excellent + good rate
Time Frame: 12 hours after the first administration
12 hours after the first administration
The number of medication required for effective hemostasis within 12 hours
Time Frame: 12 hours after the first administration
12 hours after the first administration
The amount of medication (U/kg) required for effective hemostasis within 12 hours
Time Frame: 12 hours after the first administration
12 hours after the first administration
8-hours effective hemostasis rate
Time Frame: 8 hours after the first administration
8 hours after the first administration
8-hours excellent + good rate
Time Frame: 8 hours after the first administration
8 hours after the first administration
Complete + significant relief rate
Time Frame: 4 hours, 8 hours, 12 hours, 24 hours after the first administration
4 hours, 8 hours, 12 hours, 24 hours after the first administration
The time to achieve complete/significant remission after the first administration
Time Frame: From the time after the first administration until within 72 hours after the last administration
From the time after the first administration until within 72 hours after the last administration
Rescue treatment rate
Time Frame: Within 72 hours after the last administration
Within 72 hours after the last administration
The time from the onset of bleeding to complete/significant relief
Time Frame: Within 72 hours after the last administration
Within 72 hours after the last administration
The effective hemostasis rate of the target joint
Time Frame: From 12 hours after the first administration to 72 hours after the last administration
From 12 hours after the first administration to 72 hours after the last administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu BioJeTay Biotechnology Co., Ltd.

Investigators

  • Principal Investigator: Lei Zhang, Ph.D, Hospital of Hematology, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STSP-0601-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemophilia

Clinical Trials on STSP-0601 for Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe