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Completed

NCT Number: NCT05265286

A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

Primary objective: To assess the pharmacokinetics, Safety and immunogenicity of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A(FRSW117) Secondary objectives: To assess Preliminary efficacy of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A.

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Key information

Conditions

Severe 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 Hemophilia A Hemorrhagic Disorders

Age range

12 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

People'S Hospital of Zhengzhou, Zhengzhou, Henan, China

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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%.
  • 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.• Significant hepatic or renal impairment (ALT and AST > 2×ULN; serum bilirubin level > 2 × upper limit of normal (ULN), Urea /BUN > 2×ULN, Cr > 176.8 µmol/L)
  • 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 screening
  • 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

Other protocol-defined inclusion/exclusion Criteria May Apply.

Treatment and study plan

FRSW117

Drug

Subjects of high dose group are being received four doses(50 IU/kg,once a week or every 7 days) of FRSW117.

Subjects of low dose group (40 IU/kg,once a week or every 7 days)are being received four doses of FRSW117.

Other names: PEG 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 10 days

    Measured by One-Stage 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 10 days

    Measured by One-Stage Clotting Assay

  3. Area Under the Curve to Infinity (AUC)

    Time frame: Pre-dose and post dose up to 10 days

    Measured by One-Stage 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 10 days

    Measured by One-Stage Clotting Assay

  5. Evaluation of the level of anti-PEG-rFⅧFc antibody production in participants

    Time frame: Pre-dose and post dose up to 36 days

  6. Evaluation of the level of anti-PEG antibody production in participants

    Time frame: Pre-dose and post dose up to 36 days

Secondary outcomes

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

    Time frame: Pre-dose and post dose up to 36 days

    Adverse events related to PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein 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 36 days

    Measured by the Nijmegen-Modified Bethesda Assay

  3. score of bleeding symptoms and Vital signs

    Time frame: Pre-dose and post dose up to 36 days

    Response to treatment with PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for bleeding episodes, using the 4-point bleeding response scale

Sponsors and collaborators

Lead sponsor

Hangzhou Gensciences Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2022
Registry last updated
May 15, 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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