A Study to Evaluate the Pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

NCT ID: NCT03747653

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-08
• Study Completion Date: 2020-05-31

Brief Summary

Primary objective: To assess the pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc fusion protein for Injection at two dose levels in patients with hemophilia A.

Secondary objectives: To assess Safety and Tolerability by monitoring FVIII recovery and adverse events in patients with hemophilia A.

Conditions

Hemophilia A

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Arm 1

Participants will receive a single intravenous (i.v.) injection of ADVATE followed by a single intravenous (i.v.) injection of Recombinant Human Coagulation Factor VIII-Fc fusion protein for Injection (FRSW107) at a low dose.

ADVATE

Intervention Type: DRUG

Patients will be administered a single dose of ADVATE.

FRSW107

Intervention Type: DRUG

Patients will be administered a single dose of FRSW107 for Injection.

Arm 2

Participants will receive a single intravenous (i.v.) injection of ADVATE followed by a single intravenous (i.v.) injection of Recombinant Human Coagulation Factor VIII-Fc fusion protein for Injection (FRSW107) at a high dose.

ADVATE

Intervention Type: DRUG

Patients will be administered a single dose of ADVATE.

FRSW107

Intervention Type: DRUG

Patients will be administered a single dose of FRSW107 for Injection.

Interventions

ADVATE

Patients will be administered a single dose of ADVATE.

Intervention Type: DRUG

FRSW107

Patients will be administered a single dose of FRSW107 for Injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 12 years to 60 years, male.
• The activity of the coagulation factor VIII (FVIII:C) < 2%, and previously treated with FVIII concentrate (s) for a minimum of 150 exposure days (EDs) prior to study entry.
• Non-immune deficiency (CD4 > 200/μL).
• Non-acute hemorrhagic state.
• No history of a positive inhibitor test (< 0.6 BU) or clinical signs of decreased response to FVIII administrations. No Family history of inhibitors.
• Platelet count > 100,000 platelets/μL.
• Normal prothrombin time or INR < 1.3.
• Normal thrombin time (TT).
• Normal previous results of vWF antigen examination.
• Negative lupus anticoagulant .
• Capable of understanding and willing to comply with the conditions of the protocol have read (patient and/or guardian).

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 IgG2 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 4 days prior screening or within 72 h prior to administration.
• Patients with severe heart disease, including myocardial infarction, heart failure (III or higher level).
• Clinically significant of other systematic diseases: alcoholism, drug abuse, mental disorders and mental retardation.
• Significant hepatic or renal impairment (ALT and AST > 2×ULN; serum bilirubin level > 3 × upper limit of normal (ULN) , BUN > 2×ULN, Cr > 2.0 mg/dL).
• 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 1 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Furen Biomedical Research Institute Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Kaifeng Pharmaceutical (Group) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renchi Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Southern Medical University Nanfang Hospital

Guangzhou, Guangzhou, China

Jinan Central Hospital

Jinan, Shandong, China

Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, Tianjin Municipality, China

Hematology Department, Beijing Children's Hospital, Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

CTR20182090

Identifier Type: -

Identifier Source: org_study_id