ADVATE Post Authorization Safety Surveillance

NCT ID: NCT00214734

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-14

Study Completion Date

2007-03-02

Brief Summary

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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

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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rAHF-PFM

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Baxter BioScience

INDUSTRY

Sponsor Role collaborator

Baxalta now part of Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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PHOENIX CHILDRENS Hospital

Phoenix, Arizona, United States

Site Status

Arkansas Childrens Hospital

Little Rock, Arkansas, United States

Site Status

City of Hope National Medical Center

Duarte, California, United States

Site Status

LONG BEACH MEMORIAL MED Center

Long Beach, California, United States

Site Status

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

Los Angeles, California, United States

Site Status

Valley Children'S Hospital

Madera, California, United States

Site Status

Children'S Hospital of S.W. Florida

Fort Myers, Florida, United States

Site Status

BIODORON

Hollywood, Florida, United States

Site Status

Nemours Children'S Clinic

Jacksonville, Florida, United States

Site Status

NEMOURS CHILDREN'S CLINIC- Orlando

Orlando, Florida, United States

Site Status

Tampa Children'S Hospital At St. Joes

Tampa, Florida, United States

Site Status

University of Southern Florida

Tampa, Florida, United States

Site Status

Rush Presbyterian - St. Lukes Medical Center

Chicago, Illinois, United States

Site Status

Children´s Memorial Hospital

Chicago, Illinois, United States

Site Status

Indiana Hemophilia & Thrombosis Center

Indianapolis, Indiana, United States

Site Status

University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics

Iowa City, Iowa, United States

Site Status

Tulane Univ Hosp & Clinic

New Orleans, Louisiana, United States

Site Status

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

University of Michigan Med. Ctr Htc

Ann Arbor, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

PHS DEVOS CHILDRENS Hospital

Grand Rapids, Michigan, United States

Site Status

MUNSON MED Center

Traverse City, Michigan, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

St. Louis Children'S Hospital

St Louis, Missouri, United States

Site Status

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Site Status

Ted R. Montoya Hemophilia Treatment Center

Albuquerque, New Mexico, United States

Site Status

North Carolina Baptist Hospital, Hematology/Oncology Medical Center Boulevard

Winston-Salem, North Carolina, United States

Site Status

Phs Childrens Hosp Med Ctr Akron

Akron, Ohio, United States

Site Status

Children´s Hospital Medical Center Pharmacy, Hemophilia Treatment Center

Cincinnati, Ohio, United States

Site Status

Youngstown HTC

Youngstown, Ohio, United States

Site Status

Childrens Hosp of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Site Status

St. Christopher´s Hospital for Children, Section of Hematology/Oncology

Philadelphia, Pennsylvania, United States

Site Status

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Phs-So Tx Hemo Ctr-San Antonio

San Antonio, Texas, United States

Site Status

Children'S Hospital of the King'S Daughters

Norfolk, Virginia, United States

Site Status

Countries

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United States

Related Links

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https://clinicaltrials.takeda.com/study-detail/5f6b5fc94db2bf003ab46231

To obtain more information on the study, click here/on this link.

Other Identifiers

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ADVATE PASS

Identifier Type: -

Identifier Source: org_study_id

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