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 Shire21 enrolled

Overview

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

Enrollment

Conditions

Hemophilia A

Interventions

Octocog alfa (recombinant human coagulation factor VIII)BIOLOGICAL

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (6)

Institute of Hematology and Oncology, Harbin The First Hospital

Harbin, Heilongjiang, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

Nanjing Children's Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, China