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

Jiangsu Gensciences

Status and phase

Completed

Phase 1

Conditions

Hemophilia A

Treatments

Drug: FRSW107

Drug: ADVATE

Study type

Interventional

Funder types

Industry

Identifiers

NCT05251090

CTR20220279

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

Male

Ages

Under 12 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.