Hemophilia A Clinical Trial
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
Verified date | May 2020 |
Source | Kaifeng Pharmaceutical (Group) Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 12 |
Est. completion date | May 31, 2020 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 12 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Hematology Department, Beijing Children's Hospital, Capital Medical University | Beijing | |
China | Fujian Medical University Union Hospital | Fuzhou | Fujian |
China | Southern Medical University Nanfang Hospital | Guangzhou | Guangzhou |
China | Jinan Central Hospital | Jinan | Shandong |
China | Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Kaifeng Pharmaceutical (Group) Co., Ltd. | Beijing Furen Biomedical Research Institute Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum measured concentration of FVIII:C (Cmax). | Measured by the One-stage aPTT Clotting Assay. | Pre-dose and post dose of FRSW107 up to 10 days. | |
Primary | Time required for the concentration of the drug to reach half of its original value (T1/2). | Measured by the One-stage aPTT Clotting Assay. | Pre-dose and post dose of FRSW107 up to 10 days. | |
Primary | Area Under the Curve to Infinity (AUC). | Measured by the One-stage aPTT Clotting Assay. | Pre-dose and post dose of FRSW107 up to 10 days. | |
Primary | 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). | Measured by the One-stage aPTT Clotting Assay. | Pre-dose and post dose of FRSW107 up to 10 days. | |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE V5.0. | Adverse events related to Recombinant Human Coagulation Factor VIII-Fc fusion protein for Injection according to Common Terminology Criteria for Adverse Events (CTCAE) NCI.V5.0. | Post dose of FRSW107 up to 28. | |
Secondary | Development of Inhibitor. | Measured by the Nijmegen-Modified Bethesda Assay. | Pre-dose and post dose of FRSW107 up to 28 days. |
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