Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics，Safety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Lead Sponsor:
Jiangsu Gensciences lnc.
Conditions:
Severe Hemophilia A
Eligibility:
MALE
12-65 years
Phase:
PHASE1
Brief Summary
The primary objectives of the study are to evaluate the Pharmacokinetics，Safety and tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW117) in patients ...
Eligibility Criteria
Inclusion
- Patients with clinically confirmed hemophilia A (coagulation factor VIII \<1%) and previous medical records confirming exposure to coagulation factor VIII for ≥150 days (EDs ≥150).
- Non-immunodeficient, with some immunity (CD4 \> 200/μL).
- Platelet count \>100×10\^9/L.
- Normal prothrombin time (PT) or international normalized ratio (INR) \<1.3.
- Negative lupus anticoagulant.
- Fully understand, informed about this study and sign the informed consent form, voluntarily participate in the clinical study and have the ability to complete all study procedures
Exclusion
- Hypersensitivity to the test substance or its excipients (including rodent or hamster protein).
- Pre-existing hypersensitivity or allergic reactions to FVIII or IgG2 injection therapy.
- Positive FVIII inhibitor at screening (≥0.6 BU/mL), or previous history of FVIII inhibitor Positive history, or family history of inhibitors.
- Patients with other coagulation disorders in addition to hemophilia A.
- The results of vWF antigen examination lower than normal.
- Severe anemia and need blood transfusion (hemoglobin \< 60g/L).
- Patients who have received any standard half-lives FVIII formulations (e.g., Kogenate, Kovaltry, Advate, Xyntha, etc.) or received any other half-life-extending FVIII formulations within 4 days or 5 half-lives (whichever is longer) before administration.
- Patients who had used emecizumab within 6 months prior to administration.
- Patients with fever, upper respiratory tract infection or allergy symptoms within the previous 2 weeks before screening.
- Suffer from other diseases that may increase the risk of bleeding or the risk of thrombosis.
- Severe cardiovascular and cerebrovascular diseases: such as cerebral hemorrhage, stroke, myocardial infarction, unstable angina pectoris, congestive heart failure(the current New York Heart Association cardiac function grade III, Hypertension that cannot be controlled with drug treatment: systolic blood pressure\> 160 mmHg or diastolic blood pressure\> 95 mmHg.
- 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)).
- Abnormal kidney function: BUN \> 2×ULN, Cr \> 2.0mg/dL.
- One or more clinically significant tests for Hepatitis B Virus Surface Antigen, Human Immunodeficiency Virus (HIV), Antisyphilitic spirulina (TPHA) and Hepatitis C Virus (HCV) Antibody.
- Patients who received any anticoagulant or antiplatelet therapy within a week prior screening or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials.
- Systemic immunomodulators (e.g., corticosteroids \[equivalent dose of 10 mg/ day prednisone\], A-interferon, immunoglobulin, cyclophosphamide, cyclosporine, etc.) were used within 14 days prior to administration or during the study period.
- Patients having major surgery or receiving blood or blood 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 a 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.
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04864743
Start Date
June 22 2021
End Date
October 17 2021
Last Update
September 8 2023
Active Locations (4)
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1
Nanfang Hospital of Southern Medical University
Guangzhou, Guangzhou, China, 510515
2
People's Hospital of Zhengzhou
Zhengzhou, Henan, China, 450053
3
Jinan central hospital
Jinan, Shandong, China, 250013
4
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College.
Tianjin, Tianjin Municipality, China, 300020