ADVATE Post Authorization Safety Surveillance

This study has been completed.

Sponsor:

Collaborator:

Baxter BioScience

Information provided by:

Baxter Healthcare Corporation

ClinicalTrials.gov Identifier:

NCT00214734

First received: September 15, 2005

Last updated: April 1, 2009

Last verified: April 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 15, 2005

Last Updated Date

April 1, 2009

Start Date ^ICMJE

August 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00214734 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

ADVATE Post Authorization Safety Surveillance

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Hemophilia A

Intervention ^ICMJE

Drug: rAHF-PFM

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

450

Completion Date

January 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00214734

Other Study ID Numbers ^ICMJE

ADVATE PASS

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Baxter Healthcare Corporation

Collaborators ^ICMJE

Baxter BioScience

Investigators ^ICMJE

Study Director:

Bruce Ewenstein, MD

Baxter BioScience

Information Provided By

Baxter Healthcare Corporation

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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