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

Jiangsu Gensciences

Status and phase: Completed; Phase 2

Conditions: Severe Hemophilia A

Treatments: Drug: FRSW117

Study type: Interventional

Funder types: Industry

Identifiers

NCT05265286

CTR20220283

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Arm 1 prophylaxis treatment

Experimental group

Description:

Subjects of high dose group are being received four doses of FRSW117. dosing on day1(ED1), day8(ED2), day15(ED3), day22(ED4) respectively. Subjects of low dose group are being received four doses of FRSW117. dosing on day1(ED1), day8(ED2), day15(ED3), day22(ED4) respectively. All subjects are being received PK assessment in ED1 and ED4.

Treatment:

Drug: FRSW117