MedPath

ADVATE Post Authorization Safety Surveillance

Completed
Conditions
Hemophilia A
Registration Number
NCT00214734
Lead Sponsor
Baxalta now part of Shire
Brief Summary

The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
108
Inclusion Criteria
  • Subject has moderate or severe hemophilia A (baseline FVIII less than or equal to 5%)
  • Subject currently has no measurable FVIII inhibitor titer greater than or equal to 1 BU (Bethesda or Nijmegen method)
  • Subject has been prescribed ADVATE by their treating physician
  • Subject may be of any age
  • Subject or parent/legally authorized representative has provided written informed consent
Exclusion Criteria
  • None

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (37)

PHOENIX CHILDRENS Hospital

🇺🇸

Phoenix, Arizona, United States

Arkansas Childrens Hospital

🇺🇸

Little Rock, Arkansas, United States

City of Hope National Medical Center

🇺🇸

Duarte, California, United States

LONG BEACH MEMORIAL MED Center

🇺🇸

Long Beach, California, United States

Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology

🇺🇸

Los Angeles, California, United States

Valley Children'S Hospital

🇺🇸

Madera, California, United States

Children'S Hospital of S.W. Florida

🇺🇸

Fort Myers, Florida, United States

BIODORON

🇺🇸

Hollywood, Florida, United States

Nemours Children'S Clinic

🇺🇸

Jacksonville, Florida, United States

NEMOURS CHILDREN'S CLINIC- Orlando

🇺🇸

Orlando, Florida, United States

Scroll for more (27 remaining)
PHOENIX CHILDRENS Hospital
🇺🇸Phoenix, Arizona, United States

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