ADVATE Post Authorization Safety Surveillance

March 16, 2021 updated by: Baxalta now part of Shire

Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A- An ADVATE Post-authorization Safety Surveillance (PASS) Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Childrens Hospital
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Childrens Hospital
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Long Beach, California, United States, 90806
        • LONG BEACH MEMORIAL MED Center
      • Los Angeles, California, United States, 90027
        • Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology
      • Madera, California, United States, 93638
        • Valley Children's Hospital
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Children'S Hospital of S.W. Florida
      • Hollywood, Florida, United States, 33021
        • BIODORON
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Clinic
      • Orlando, Florida, United States, 32801
        • NEMOURS CHILDREN'S CLINIC- Orlando
      • Tampa, Florida, United States, 33607
        • Tampa Children'S Hospital At St. Joes
      • Tampa, Florida, United States, 33612
        • University of Southern Florida
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - St. Lukes Medical Center
      • Chicago, Illinois, United States, 60614
        • Children´s Memorial Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Indiana Hemophilia & Thrombosis Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Univ Hosp & Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • The Johns Hopkins Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Med. Ctr Htc
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49503
        • PHS DEVOS CHILDRENS Hospital
      • Traverse City, Michigan, United States, 49684
        • MUNSON MED Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson University Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Ted R. Montoya Hemophilia Treatment Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • North Carolina Baptist Hospital, Hematology/Oncology Medical Center Boulevard
    • Ohio
      • Akron, Ohio, United States, 44308
        • Phs Childrens Hosp Med Ctr Akron
      • Cincinnati, Ohio, United States, 45229
        • Children´s Hospital Medical Center Pharmacy, Hemophilia Treatment Center
      • Youngstown, Ohio, United States, 44501
        • Youngstown HTC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Presbyterian Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Childrens Hosp of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19134-1095
        • St. Christopher´s Hospital for Children, Section of Hematology/Oncology
    • Tennessee
      • Knoxville, Tennessee, United States, 37920-6999
        • University of Tennessee Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78207
        • Phs-So Tx Hemo Ctr-San Antonio
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Children's Hospital of The King's Daughters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxalta now part of Shire

Collaborators

Baxter BioScience

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 14, 2004

Study Completion (ACTUAL)

March 2, 2007

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADVATE PASS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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