Skip to main content
OpenTrials
Completed

NCT Number: NCT04747964

A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor

This study will assess the pharmacokinetics and pharmacodynamics of STSP-0601 at six dose levels. The results will help identify the most optimal doses to treat bleedings in hemophilia patients with inhibitors.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old ≤age≤65 years of age,male.
  • Hemophilia A or B patients with inhibitors.
  • Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
  • Establish proper venous access.
  • Provide signed informed consent.

Exclusion criteria

  • 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 an active, ongoing bleeding for which the patient is being treated, or treatment for a bleeding was stopped within 7d of the time of study drug administration.
  • Have a history of arterial and/or venous thromboembolic events.
  • Have platelet count <100,000/mL.
  • Severe liver or kidney disease.
  • Accept major operation or blood transfusion within 1 month of the time of screening.
  • HIV antibody positive.
  • Have a known allergy to Blood product.
  • Participate in other clinical research within 1 month of the time of study drug administration.

Treatment and study plan

STSP-0601 for Injection

Drug

Subjects will receive one single lowest dose of STSP-0601 for Injection following protocol requirements

Primary outcomes

  1. Number of subjects of adverse events

    Time frame: Baseline to Day 8

  2. Number of subjects With Significant Abnormal Physical Examination

    Time frame: Baseline to Day 8

  3. Number of subjects of Significant Abnormal Vital Signs Findings

    Time frame: Baseline to Day 8

  4. Number of Participants With Significant Abnormal Laboratory Values

    Time frame: Baseline to Day 8

  5. Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings

    Time frame: Baseline,1 hour,4 hour,48 hour,Day 8

Secondary outcomes

  1. Activated partial thromboplastin time

    Time frame: Baseline to 24 hours

  2. Thrombin production (TG) peak

    Time frame: Baseline to 24 hours

Sponsors and collaborators

Lead sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd

Industry

Registry information

Official study title

A Phase 1,Multi-center, Randomized, Open, Single-dose Escalation Design to Evaluate the Safety, Tolerability and Pharmacodynamics of STSP-0601 for Injection in Patients With Inhibitory Hemophilia

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.