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

Baxalta

Status: Completed

Conditions: Hemophilia A

Treatments: Biological: Octocog alfa (recombinant human coagulation factor VIII)

Study type: Observational

Funder types: Industry

Identifiers

NCT02634723

061501

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

21 participants in 1 patient group

Previously Untreated Patients (PUPs)

Description:

PUPs in China with Moderate to Severe Hemophilia A

Treatment:

Biological: Octocog alfa (recombinant human coagulation factor VIII)