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

NCT ID: NCT05251090

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-16
• Study Completion Date: 2022-05-09

Brief Summary

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.

Conditions

Hemophilia A

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Subjects(up to 12 years of age) received two treatments: 50 IU/kg ADVATE in the first period, followed by 50 IU/kg FRSW107 in the second period.

Group Type: EXPERIMENTAL

ADVATE

Intervention Type: DRUG

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

FRSW107

Intervention Type: DRUG

50 IU/kg, a single dose.

Interventions

ADVATE

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

Intervention Type: DRUG

FRSW107

50 IU/kg, a single dose.

Intervention Type: DRUG

Other Intervention Names

Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection

Eligibility Criteria

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.

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.

• Maximum Eligible Age: 12 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Gensciences lnc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Runhui Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Children's Hospital

Xiaoling Wang, MA.Sc

Role: PRINCIPAL_INVESTIGATOR

Beijing Children's Hospital

Locations

Beijing Children's Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Shenzhen Children's Hospita

Shenzhen, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangzhou, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Countries

China

Other Identifiers

CTR20220279

Identifier Type: -

Identifier Source: org_study_id