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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):

Tracking Information
First Submitted Date  ICMJE October 2, 2008
First Posted Date  ICMJE October 3, 2008
Results First Submitted Date  ICMJE December 16, 2011
Results First Posted Date  ICMJE January 20, 2012
Last Update Posted Date January 20, 2012
Study Start Date  ICMJE February 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
percentage of patients with FVIII inhibitor development [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
incidence of non-serious adverse events; serious adverse events; incidence of less-than-expected therapeutic effect [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study Evaluating The Safety Of Xyntha In Usual Care Settings
Official Title  ICMJE A Postauthorization Safety Surveillance Study Of Xyntha In Usual Care Settings
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hemophilia A
Intervention  ICMJE
  • 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
Study Arms  ICMJE Moroctocog alfa(AF-CC)
  • Biological: Moroctocog alfa(AF-CC)
  • Procedure: Blood draw for laboratory testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 10, 2011)
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2008)
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE New Zealand,   United States
Removed Location Countries Australia,   Canada,   Colombia
Administrative Information
NCT Number  ICMJE NCT00765726
Other Study ID Numbers  ICMJE 3082B2-4418
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer Call Center Pfizer
PRS Account Pfizer
Verification Date December 2011

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