Brief Title
Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated Patients in China With Moderate to Severe Hemophilia A
Official Title
Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated Patients in China With Moderate to Severe Hemophilia A
Brief Summary
The purpose of this post-marketing safety study is to evaluate the safety, immunogenicity, and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate to severe hemophilia A.
Study Type
Observational
Primary Outcome
Number of high titer, low titer and transient Factor VIII (FVIII) inhibitors developed
Secondary Outcome
Number and type of bleeding episodes treated with ADVATE
Condition
Hemophilia A
Intervention
Octocog alfa (recombinant human coagulation factor VIII)
Study Arms / Comparison Groups
Previously Untreated Patients (PUPs)
Description: PUPs in China with Moderate to Severe Hemophilia A
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
21
Start Date
December 2015
Completion Date
June 2016
Primary Completion Date
June 2016
Eligibility Criteria
Inclusion Criteria: 1. Previously untreated patient (PUP) in China with moderate to severe hemophilia A. 2. Investigator prescribed ADVATE as the predominant therapeutic agent for the management of hemophilia A 3. Informed consent form from patient and/or legal representative will need to be signed per local regulation Exclusion Criteria: 1. Presence of an inherited or acquired hemostatic defect other than hemophilia A, and any other clinically significant chronic disease 2. Participants who participated in another investigational FVIII drug study, or had participated in any clinical study involving an investigational FVIII drug during the course of the observation period
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Leonard Valentino, MD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02634723
Organization ID
061501
Responsible Party
Sponsor
Study Sponsor
Baxalta now part of Shire
Study Sponsor
Leonard Valentino, MD, Study Director, Shire
Verification Date
June 2016