Brief Title
A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection
Official Title
A Phase I, Multicentre, Open-label Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection in Children With Severe Hemophilia A
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.
Study Phase
Phase 1
Study Type
Interventional
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: 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.
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
28
Start Date
April 30, 2022
Completion Date
September 20, 2022
Primary Completion Date
July 2, 2022
Eligibility 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.
Gender
Male
Ages
N/A - 12 Years
Accepts Healthy Volunteers
No
Contacts
Runhui Wu, PhD, +86-010-67806990, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT05251090
Organization ID
CTR20220279
Responsible Party
Sponsor
Study Sponsor
Jiangsu Gensciences lnc.
Study Sponsor
Runhui Wu, PhD, Principal Investigator, Beijing Children's Hospital
Verification Date
February 2022