Study Evaluating The Safety Of Xyntha In Usual Care Settings

Hemophilia A Clinical Trial

Official title:

A Postauthorization Safety Surveillance Study Of Xyntha In Usual Care Settings

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00765726
• Other study ID #: 3082B2-4418
• Secondary ID: B1831003
• Status: Terminated
• Phase: Phase 4
• First received: October 2, 2008
• Last updated: December 16, 2011
• Start date: February 2009
• Est. completion date: August 2011

Study information

• Verified date: December 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to collect safety information associated with the use of Xyntha in a usual care setting. Upon meeting eligibility criteria, patients will be required to have approximately 5 study visits over a 2 year period. Procedures completed throughout the study include collection of vital signs, physical exams, and laboratory assessments. Patients will be required to complete an infusion log for each Xyntha infusion.

Description:

The study was terminated on May 12, 2011 due to poor enrollment prospects and the study's similarity to another ongoing trial with ReFacto AF.

The termination of this study has no impact on subject safety or well being. The decision to terminate the trial was not based on any safety concerns.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Male patients 12 years of age and older.

• Patients transitioned to Xyntha from other recombinant or plasma-derived FVIII replacement products.

• Treatment history of 150 or greater exposure days to any FVIII products prior to Enrollment visit.

• Negative inhibitor at screening or documentation of negative inhibitor titer within 6 weeks or less prior to study entry except for patients entering the study on immune tolerance induction therapy.

Exclusion Criteria:

• Bleeding disorder other than hemophilia A.

• Inhibitor titer greater than or equal to 0.6 BU during screening except for patients on immune tolerance induction therapy.

• Immunomodulatory therapy during screening period.

• Known hypersensitivity to hamster protein.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Biological:
• Moroctocog alfa(AF-CC)
Dosing is at the discretion of the investigator during the study

Procedure:
• Blood draw for laboratory testing
Hematology and Chemistry panels, Factor VIII inhibitor and recovery studies

Locations

Country	Name	City	State
New Zealand	Pfizer Investigational Site	Christchurch
United States	Pfizer Investigational Site	Dayton	Ohio
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	East Lansing	Michigan
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Factor VIII (FVIII) Inhibitor Development	FVIII inhibitor development was defined as an inhibitor titer of more than or equal to 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay and confirmed by the central laboratory.	Month 24 or early withdrawal	Yes

External Links

•   To obtain contact information for a study center near you, click here.