Clinical trial
A Phase II, Multicentre, Open-label Study to Evaluate the Pharmacokinetic, Safety and Preliminary Efficacy of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Subjects With Severe Hemophilia A
Name
CTR20220283
Description
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(FRSW117) Secondary objectives: To assess Preliminary efficacy of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A.
Trial arms
Trial start
2022-04-14
Estimated PCD
2022-08-21
Trial end
2022-08-21
Status
Completed
Phase
Early phase I
Treatment
FRSW117
Subjects of high dose group are being received four doses(50 IU/kg,once a week or every 7 days) of FRSW117.
Subjects of low dose group (40 IU/kg,once a week or every 7 days)are being received four doses of FRSW117.
Arms:
Arm 1 prophylaxis treatment
Other names:
PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Size
15
Primary endpoint
Maximum measured concentration of FVIII:C (Cmax)
Pre-dose and post dose up to 10 days
Time required for the concentration of the drug to reach half of its original value (T1/2)
Pre-dose and post dose up to 10 days
Area Under the Curve to Infinity (AUC)
Pre-dose and post dose up to 10 days
The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time (CL)
Pre-dose and post dose up to 10 days
Evaluation of the level of anti-PEG-rFⅧFc antibody production in participants
Pre-dose and post dose up to 36 days
Evaluation of the level of anti-PEG antibody production in participants
Pre-dose and post dose up to 36 days
Eligibility criteria
Key Inclusion Criteria:
* 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 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.• 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}
Updated at
2023-05-15
1 organization
1 product
1 indication
Organization
Jiangsu Gensciences Inc.Product
FRSW117Indication
Hemophilia A