emophilia A
Conditions
Interventions
on-demand treatment group:The drug was given every three days at a dose of 50 IU/kg
Sponsors
Hematology Hospital of Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Male
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Subject and/or their guardian fully understand the purpose, nature, method and possible adverse reactions of the study, volunteer to be a subject, and subject and/or their guardian voluntarily sign the informed consent prior to the commencement of any study procedure; 2.Subjects with good compliance; 3.According to the previous treatment results, the investigators will evaluate who can continue to receive prophylactic treatment.
Exclusion criteria
Exclusion criteria: 1.The subjects unfinished the phase III clinical trial or the subjects finished the phase ? clinical trial but don't want to continue to accept the treatment; 2.The subjects did not attend the phase III clinical trial .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized bleeding rate;Number of target joints, Annualized bleeding rate of joints; | — |
Secondary
| Measure | Time frame |
|---|---|
| Doses and times of injection;World Health Organization Quality of Life with 100 question;FVIII inhibitor detection;vital signs;Physical examination;Clinical laboratory examination;ECG examination;Bleeding events;Adverse Drug Reaction;IgG Level and subclass detection;Host cell (CHO) antibody detection; | — |
Countries
China
Contacts
Public ContactYang Renchi
Hematology Hospital of Chinese Academy of Medical Sciences
Outcome results
None listed