Study Evaluating The Safety Of Xyntha In Usual Care Settings

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00765726
First received: October 2, 2008
Last updated: December 16, 2011
Last verified: December 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Postauthorization Safety Surveillance Study Of Xyntha In Usual Care Settings

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Factor VIII (FVIII) Inhibitor Development [ Time Frame: Month 24 or early withdrawal ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 12
Study Start Date: February 2009
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765726

Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00765726     History of Changes
Other Study ID Numbers: 3082B2-4418, B1831003
Study First Received: October 2, 2008
Results First Received: December 16, 2011
Last Updated: December 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
hemophilia
hemophilia A
ReFacto
Xyntha
moroctocog alfa
bleeding disorder

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014