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Recruiting NCT06922045

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

Phase III Interventional Hemophilia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: STSP-0601 for Injection.
Who it may be relevant to
Registry conditions: Hemophilia. Basic parameters: 12 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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

Primary outcome measures

  • 12 hours effective hemostasis rate [Time frame: 12 hours after the first administration]
Secondary outcome measures (11)
  • Effective hemostasis rate at the first 12 hours bleeding visit [Time frame: 12 hours after the first administration]
  • 12 hours excellent + good rate [Time frame: 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]
  • The amount of medication (U/kg) required for effective hemostasis within 12 hours [Time frame: 12 hours after the first administration]
  • 8-hours effective hemostasis rate [Time frame: 8 hours after the first administration]
  • 8-hours excellent + good rate [Time frame: 8 hours after the first administration]
  • Complete + significant relief rate [Time frame: 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]
  • Rescue treatment rate [Time frame: 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]
  • The effective hemostasis rate of the target joint [Time frame: From 12 hours after the first administration to 72 hours after the last administration]

Eligibility criteria

Inclusion criteria

  • 12 ≤age≤70 years of age.
  • Hemophilia A or B patients.
  • Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
  • Establish proper venous access.
  • There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening.
  • 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.
  • Patients plan to receive Emicizumab during the trial.
  • Patients received anticoagulant or antifibrinolytic therapy 7 days before the first administration or plan to receive these drugs during the trial.
  • 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 the first administration.
  • Accepted major operation or blood transfusion within 4 weeks before the first administration.
  • Have a known allergy to STSP-0601.
  • Pregnant, lactating, or blood pregnancy test positive female subjects
  • Participate in other clinical research within 4 weeks before enrollment (except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).
  • 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.
  • Patients not suitable for the trail according to the judgment of the investigators.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 18 centers
  • Anhui Provincial Hospital — Hefei
  • Lanzhou University First Hospital — Lanzhou
  • Nanfang Hospital, Southern Medical University — Guangzhou
  • Shenzhen Second People's Hospital — Shenzhen
  • The First affiliated hospital of Guangxi Medical University — Nanning
  • North China University of Science and Technology Affiliated Hospital — Tangshan
  • Harbin First Hospital Hematology Tumor Research Center — Harbin
  • Henan Cancer Hospital — Zhengzhou
  • … and 10 more centers

Identifiers

NCT: NCT06922045 · STSP-0601-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗