Brief Title
A Study to Evaluate the Pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Official Title
A Phase I, Multicentre, Open-label, Self-control Study to Evaluate the Pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A
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.
Study Type
Observational
Primary Outcome
Maximum measured concentration of FVIII:C (Cmax).
Secondary Outcome
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0.
Condition
Hemophilia A
Intervention
ADVATE
Study Arms / Comparison Groups
Arm 1
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
March 8, 2019
Completion Date
May 31, 2020
Primary Completion Date
May 31, 2020
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.
Gender
Male
Ages
12 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Renchi Yang, PhD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03747653
Organization ID
CTR20182090
Responsible Party
Sponsor
Study Sponsor
Kaifeng Pharmaceutical (Group) Co., Ltd.
Collaborators
Beijing Furen Biomedical Research Institute Co., Ltd.
Study Sponsor
Renchi Yang, PhD, Principal Investigator, Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Verification Date
May 2020