Ignite Creation Date:
2024-05-06 @ 3:26 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02280265
Status:
UNKNOWN
Last Update Posted:
2014-10-31
First Post:
2014-10-28
Brief Title:
Efficacy and Safety of ADVATE Standard Prophylaxis to Hemophilia A
Sponsor:
Nanjing Medical University
Organization:
Nanjing Medical University
Study Overview
Official Title:
Evaluate Efficacy and Safety of ADVATE in the Standard Prophylaxis Treatment of Severe or Moderately Severe Hemophilia A
Status:
UNKNOWN
Status Verified Date:
2014-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 severe haemophilia by WHO and World Federation Of Hemophilia WFH The efficacy and safety of prophylaxis in preventing bleeds and arthropathy in patients with hemophilia has been confirmed in well-designed clinical studiesTo keep the factor level above 1 the standard dosage for patients with severe hemophilia A is 20-40 Units kginfusion average 30 Units kg every other day or three times a week This dosage has a very high consumption of factor up to 5000-6000 international unit IUkgyear The high consumption of factor and cost present a major barrier to use the standard prophylaxis in many countries particularly in the developing world
In China the majority of boys with severe hemophilia A can only pay for on-demand treatment or low-dose prophylaxis Ao after the affordability of patients was solved and many patients will get more chance to receive standard prophylaxis
This study is designed to evaluate the Annual Bleeding rate ABR joint health outcomes and QoL outcomes in subjects using ADVATERecombinant Human Coagulation Factor VIII for injection standard prophylaxis under the conditions of routine practice
In China the majority of boys with severe hemophilia A can only pay for on-demand treatment or low-dose prophylaxis Ao after the affordability of patients was solved and many patients will get more chance to receive standard prophylaxis
This study is designed to evaluate the Annual Bleeding rate ABR joint health outcomes and QoL outcomes in subjects using ADVATERecombinant Human Coagulation Factor VIII for injection standard prophylaxis under the conditions of routine practice
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None