Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated Patients in China With Moderate to Severe Hemophilia A

Baxalta now part of Shire6 sites in 1 country21 target enrollmentDecember 23, 2015

ConditionsHemophilia A

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hemophilia A
Sponsor: Baxalta now part of Shire
Enrollment: 21
Locations: 6
Primary Endpoint: Number and type of other serious and non-serious adverse events (AEs)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 23, 2015

End Date

June 30, 2016

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Baxalta now part of Shire

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Previously untreated patient (PUP) in China with moderate to severe hemophilia A.
•Investigator prescribed ADVATE as the predominant therapeutic agent for the management of hemophilia A
•Informed consent form from patient and/or legal representative will need to be signed per local regulation

Exclusion Criteria

•Presence of an inherited or acquired hemostatic defect other than hemophilia A, and any other clinically significant chronic disease
•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

Outcomes

Primary Outcomes

Number and type of other serious and non-serious adverse events (AEs)

Time Frame: Throughout the study period of 6 months

Other AEs refers to AEs other than Factor VIII (FVIII) inhibitors

Number of high titer, low titer and transient Factor VIII (FVIII) inhibitors developed

Time Frame: Throughout the study period of 6 months

Secondary Outcomes

Total number of exposure days (EDs) to ADVATE(Throughout the study period of 6 months)
Number of bleeding episodes treated with 1, 2, 3, ≥ 4 infusions of ADVATE(Throughout the study period of 6 months)
Annualized joint bleeding rate (AJBR) of participants treated prophylactically and on-demand with ADVATE(Throughout the study period of 6 months)
Total units of all Factor VIII (FVIII) products administered(Throughout the study period of 6 months)
Total units of ADVATE administered(Throughout the study period of 6 months)
Number and type of bleeding episodes treated with ADVATE(Throughout the study period of 6 months)
Annualized bleeding rate (ABR) of participants treated prophylactically and on-demand with ADVATE(Throughout the study period of 6 months)
Total number of exposure days (EDs) to all Factor VIII (FVIII) products(Throughout the study period of 6 months)