A Phase II, Muti-Center Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Subjects With Severe Hemophilia A

• Status: Not yet recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Gensciences lnc.
• Treatments: Factor VIII

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.