Brief Title
ADYNOVATE Drug Use-Results Survey
Official Title
ADYNOVATE Drug Use-Results Survey
Brief Summary
The purpose of this survey is to understand the following items in the actual clinical use of ADYNOVATE in patients: 1. Unexpected adverse drug reactions 2. Occurrence of adverse drug reactions in the actual clinical use 3. Factors that may affect safety and efficacy 4. Occurrence of Factor VIII inhibitor development in patients with coagulation factor VIII deficiency (hereinafter hemophilia A) 5. Safety and efficacy for hemophilia A patients who received routine prophylactic therapy and on-demand therapy
Study Type
Observational
Primary Outcome
Participants who discontinued the use of ADYNOVATE - previously treated patients (PTPs)
Secondary Outcome
Participants who experience shock or anaphylaxis - previously treated patients (PTPs)
Condition
Hemophilia A
Intervention
ADYNOVATE
Study Arms / Comparison Groups
Previously treated patients (PTPs)
Description: PTPs: patients who had 4 or more days to other Factor VIII (FVIII) products
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
145
Start Date
April 12, 2017
Completion Date
January 31, 2023
Primary Completion Date
January 31, 2023
Eligibility Criteria
Inclusion Criteria: - Hemophilia A patients who receive ADYNOVATE, including previously treated patients with Factor VIII deficiency (PTPs), and previously untreated patients with Factor VIII deficiency (PUPs) who are treated with ADYNOVATE. Exclusion Criteria: - Patients not administered ADYNOVATE.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Study Director, +1 866 842 5335, [email protected]
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT03169972
Organization ID
261601
Responsible Party
Sponsor
Study Sponsor
Shire
Collaborators
Takeda
Study Sponsor
Study Director, Study Director, Shire
Verification Date
March 2022