Status:
COMPLETED
A Study of Repeat Dosing 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:
PHASE2
Brief Summary
Primary objective: To assess the pharmacokinetics, Safety and immunogenicity of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A(...
Eligibility Criteria
Inclusion
- Key
- The activity of the coagulation factor VIII (FVIII:C) \< 1%.
- 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
- 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.• Significant hepatic or renal impairment (ALT and AST \> 2×ULN; serum bilirubin level \> 2 × upper limit of normal (ULN), Urea /BUN \> 2×ULN, Cr \> 176.8 µmol/L)
- 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 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
- Other protocol-defined inclusion/exclusion Criteria May Apply.
Key Trial Info
Start Date :
April 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05265286
Start Date
April 14 2022
End Date
August 21 2022
Last Update
May 15 2023
Active Locations (5)
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1
People'S Hospital of Zhengzhou
Zhengzhou, Henan, China, 450000
2
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China, 214100
3
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
4
People'S Hospital of Rizhao
Rizhao, Shandong, China, 276800