ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)

Baxalta

Status

Completed

Conditions

Hemophilia A

Treatments

Biological: ADYNOVI

Biological: ADVATE

Study type

Observational

Funder types

Industry

Identifiers

NCT02078427

061001

Details and patient eligibility

About

The purpose of the study is to document the natural history of hemophilia A disease and long-term outcomes in terms of effectiveness, safety and quality of life in participants receiving Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) or Antihemophilic Factor (Recombinant) - Pegylated (rAHF-PEG) in routine clinical practice

Enrollment

951 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Participant has hemophilia A {FVIII lesser than or equal to (<=)5%}
Participant is prescribed Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) or Antihemophilic Factor (Recombinant) - Pegylated (rAHF-PEG) by the treating physician
Participant or participant's legally authorized representative provides informed consent

Exclusion criteria

Participant has known hypersensitivity to the active substance or any of the excipients
Participant has known allergic reaction to mouse or hamster proteins
Participant has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving another FVIII concentrate or device during the course of this study