ADVATE 2 mL Post-Authorization Safety Surveillance (PASS)

Baxalta

Status: Completed

Conditions: Congenital Factor VIII (FVIII) Deficiency; Hemophilia A

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02093741

061101

Details and patient eligibility

About

This is a Post-Authorization Safety Surveillance (PASS) study designed to collect data on the safety and effectiveness of ADVATE reconstituted in 2 mL Sterile water for injection (SWFI) during routine clinical practice in children until 12 years of age. This surveillance study is a post-licensure commitment for ADVATE reconstituted in 2 mL SWFI.

Enrollment: 65 patients

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe or moderately severe hemophilia A (baseline Factor VIII (FVIII) ≤ 2%)
• ≤12 years of age
• Participant's legally authorized representative(s) has provided written informed consent
• Participant is prescribed ADVATE and will only receive ADVATE reconstituted in 2 mL sterile water for injection (SWFI)
• Documented history of prior exposure to ADVATE
• Documented evidence of negative inhibitor test result during ≤10 EDs prior to study entry

Exclusion criteria

• Known hypersensitivity to the active substance or to any of the excipients
• Known allergic reaction to mouse or hamster proteins
• Participant has a requirement for a major surgical procedure at the time of enrollment
• Participant has no prior exposure to a FVIII concentrate
• Participant currently being treated with an immune tolerance induction (ITI) regimen
• Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrand disease)
• Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device or PASS registry during the course of this study

Trial design

65 participants in 1 patient group

ADVATE - 2mL

Treatment:

Biological: Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]