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Completed

NCT Number: NCT05251090

A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ，Fc Fusion Protein for Injection

Primary objective: To assess the pharmacokinetics of Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection (FRSW107) Secondary objectives: To assess Safety and Tolerability by monitoring FVIII recovery and adverse events in Severe Hemophilia A.

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Key information

Conditions

Hemophilia A 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 Hemorrhagic Disorders

Age range

Up to 12 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Children's Hospital,Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • The activity of the coagulation factor VIII (FVIII:C) < 1%. Less than 6 years old Patients previously treated with FVIII concentrate (s) for a minimum of 50 exposure days (EDs) prior to study entry. 6 years old to 12 years old Patients previously treated with FVIII concentrate (s) for a minimum of 150 exposure days (EDs) prior to study entry.
  • Normal prothrombin time or INR < 1.3.
  • Negative lupus anticoagulant.

Key Exclusion Criteria:

  • Hypersensitive to any of the excipients of the test materials (e.g. allergic to murine or hamster origin heterologous proteins).
  • History of hypersensitivity or anaphylaxis associated with any FVIII or II immunoglobulin administration.
  • Current FVIII inhibitor-positive or history of FVIII inhibitor-positive.
  • Other coagulation disorder(s) in addition to hemophilia A.
  • Infusion of any products containing FVIII within 72 h prior to administration.
  • Significant hepatic or renal impairment (ALT and AST > 2×ULN; serum bilirubin level > 2 × upper limit of normal (ULN), BUN > 2×ULN, Cr > 2.0 ULN).
  • One or more clinically significant tests for Human Immunodeficiency Virus (HIV), Antisyphilitic spirulina (TPHA) and Hepatitis C Virus (HCV) Antibody.
  • Patients who received any anticoagulant or antiplatelet therapy within one week prior screening or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials.
  • Patients having major surgery or receiving blood or bood components transfusion within 4 weeks prior screening or having planned major surgery schedule during the study.
  • Patients who previously participated in the other clinical trials within one month prior to administration.
  • Any life-threatening disease or condition which, according to the investigator's judgment, could not benefit from the trial participation.
  • Patient who is considered by the other investigators not suitable for clinical study.

Treatment and study plan

ADVATE

Drug

50 international units (IU)/kg, a single dose.

FRSW107

Drug

50 IU/kg, a single dose.

Other names: Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection

Primary outcomes

  1. Maximum measured concentration of FVIII:C (Cmax)

    Time frame: Pre-dose and post dose up to 8 days.

    Measured by aPTT Clotting Assay.

  2. Time required for the concentration of the drug to reach half of its original value (T1/2)

    Time frame: Pre-dose and post dose up to 8 days

    Measured by aPTT Clotting Assay.

  3. Area Under the Curve to Infinity (AUC)

    Time frame: Pre-dose and post dose up to 8 days.

    Measured by aPTT Clotting Assay.

  4. The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time (CL).

    Time frame: Pre-dose and post dose up to 8 days.

    Measured by aPTT Clotting Assay.

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE V5.0.

    Time frame: Post dose up to 32 days.

    Adverse events related to Recombinant Human Coagulation Factor VIII-Fc fusion protein for Injection according to Common Terminology Criteria for Adverse Events (CTCAE) NCI.V5.0.

  2. Development of Inhibitor

    Time frame: Pre-dose and post dose up to 32 days.

    Measured by the Nijmegen-Modified Bethesda Assay.

Sponsors and collaborators

Lead sponsor

Hangzhou Gensciences Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase I, Multicentre, Open-label Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection in Children With Severe Hemophilia A

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 22, 2022
Registry last updated
Aug 22, 2023

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.

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