Hemophilia A
Conditions
Interventions
Group of on-demand treatment:According to the condition of the disease, On-demand, the dosage range is 30 ~ 50 IU/kg or the researcher can give the appropriate therapeutic dose according to the actua
Group of preventive treatment :Dosage every three days is 50 IU/kg multiplied by the body weight of the subject
Sponsors
Hematology Hospital of Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Male
Age
12 Years to 60 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria for inclusion: 1. Men aged 12 years and less than 60 years; 2. Patients with clinically confirmed severe hemophilia A (FVII level in screening period = 150); 3. Patients who had no family history of clotting factor VIII inhibitors ( 200 / µ L); 5. Platelet count > 100000 cells / µ L in the screening period; 6. Prothrombin time was normal or INR = 3 times within 6 months); 10. The subjects and their guardians have a full understanding of the study, are able to communicate well with the researchers and complete the trial in accordance with the protocol.
Exclusion criteria
Exclusion criteria: If the subject meets any of the following criteria, the conditions for entering the test are not met: 1. Patients who are allergic to any auxiliary materials (including mice or hamster protein) of the test article; 2. There was hypersensitivity or anaphylaxis after injection of FVII or IgG2; 3. Patients with other coagulation disorders besides hemophilia A; 4. Patients with serious heart disease, including myocardial infarction and cardiac insufficiency of grade 3 or above; 5. Patients with other systemic diseases of clinical significance, alcoholism, drug abuse, mental disorders and mental disorders; 6. Patients with abnormal liver function (alt, AST 2 times higher than the upper limit of normal value, serum bilirubin 3 times higher than the upper limit of normal value) or renal function (BUN 2 times higher than the upper limit of normal value, Cr > 176.8 µ mol / L); 7. Select patients who have used any anticoagulant or antiplatelet drug treatment or need to use anticoagulant or antiplatelet drug treatment during clinical trial within 7 days before screening; 8. select the patients who have received major surgery and blood or blood component infusion within 4 weeks before the study, or plan to receive surgery during the study; 9. Patients who have participated in other clinical trials within one month before screening; 10. Patients with one or more clinically significant tests of hepatitis B surface antigen, anti human immunodeficiency virus antibody, anti Treponema pallidum specific antibody and hepatitis C virus antigen; 11. Patients with other serious diseases that the researchers think the subjects can not benefit from; 12. Subjects judged unsuitable by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bleeding symptoms and Sign improvement score;Annualized bleeding rate;Number of target joints; | — |
Secondary
| Measure | Time frame |
|---|---|
| vital signs;Physical examination;Clinical laboratory examination;ECG;Bleeding events;FVIII inhibitor detection;IgG Level and subclass detection;Host cell (CHO) antibody detection;Adverse Drug Reaction;FVIII activity in blood;Pharmacokinetic parameters;Dosage and number of injections;World Health Organization Quality of Life with 100 question; | — |
Countries
China
Contacts
Public ContactRenchi Yang
Outcome results
None listed