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Study Evaluating The Safety Of Xyntha In Usual Care Settings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00765726
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : October 3, 2008
Results First Posted : January 20, 2012
Last Update Posted : January 20, 2012
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Hemophilia A Biological: Moroctocog alfa(AF-CC) Procedure: Blood draw for laboratory testing Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Postauthorization Safety Surveillance Study Of Xyntha In Usual Care Settings
Study Start Date : February 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arm Intervention/treatment
Moroctocog alfa(AF-CC) Biological: Moroctocog alfa(AF-CC)
Dosing is at the discretion of the investigator during the study
Other Name: Xyntha

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

Primary Outcome Measures :
  1. Percentage of Participants With Factor VIII (FVIII) Inhibitor Development [ Time Frame: Month 24 or early withdrawal ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00765726

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United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90007
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20010
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48202
Pfizer Investigational Site
East Lansing, Michigan, United States, 48823
United States, Ohio
Pfizer Investigational Site
Dayton, Ohio, United States, 45404-1815
New Zealand
Pfizer Investigational Site
Christchurch, New Zealand, 8001
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer Identifier: NCT00765726    
Other Study ID Numbers: 3082B2-4418
First Posted: October 3, 2008    Key Record Dates
Results First Posted: January 20, 2012
Last Update Posted: January 20, 2012
Last Verified: December 2011
Keywords provided by Pfizer:
hemophilia A
moroctocog alfa
bleeding disorder
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII