Status:
UNKNOWN
Efficacy and Safety of ADVATE Standard Prophylaxis to Hemophilia A
Lead Sponsor:
Nanjing Medical University
Conditions:
Hemophilia A
Eligibility:
All Genders
2-18 years
Phase:
NA
Brief Summary
Hemophilia A is an X-linked recessive, congenital bleeding disorder caused by deficient or defective coagulation factor VIII (FVIII). Prophylaxis is recommended as the standard of care for boys with s...
Eligibility Criteria
Inclusion
- Subject has hemophilia A with FVIII≤2 %.
- Previously treated patients (PTPs).
- Age from 2 to 18 years.
Exclusion
- Subject has known hypersensitivity to the active substance or any of the excipients.
- Subject has known allergic reaction to mouse or hamster proteins.
- Subject has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving another FVIII concentrate or device during the course of this study.
- Subject is planned, or likely to have surgery during the study period.
- Subject has end-stage renal failure or evidence of a severe or uncontrolled systemic disease as judged by the investigator.
- Subject has full-blown Acquired Immuno Deficiency Syndrome (AIDS),determined by Cluster Determinant 4+(CD4+) and clinical presentation.
- Subject has active hepatic disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels \> 5 times the upper limit of normal).
- Subject has clinical or laboratory evidence of severe liver impairment including (but not limited to) a recent and persistent international normalized ratio (INR)\> 1.4, and/or the presence of splenomegaly and/or significant spider angioma on physical exam, and/or a history of esophageal hemorrhage or documented esophageal varices.
- The subject in the opinion of the investigator is unable or unwilling to comply with study protocol
- Subject is a family member of the investigator or site staff
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02280265
Start Date
November 1 2014
End Date
December 1 2016
Last Update
October 31 2014
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