Study Evaluating The Safety Of Xyntha In Usual Care Settings

• ClinicalTrials.gov Identifier: NCT00765726
• Recruitment Status: Terminated
• First Posted: October 3, 2008
• Results First Posted: January 20, 2012
• Last Update Posted: January 20, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: October 2, 2008
• First Posted Date: October 3, 2008
• Results First Submitted Date: December 16, 2011
• Results First Posted Date: January 20, 2012
• Last Update Posted Date: January 20, 2012
• Study Start Date: February 2009
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: October 2, 2008): percentage of patients with FVIII inhibitor development [ Time Frame: 2 years ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (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: Study Evaluating The Safety Of Xyntha In Usual Care Settings
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hemophilia A

Intervention

• 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

Moroctocog alfa(AF-CC)

Interventions:

• Biological: Moroctocog alfa(AF-CC)
• Procedure: Blood draw for laboratory testing

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 10, 2011): 12
• Original Estimated Enrollment (submitted: October 2, 2008): 250
• Actual Study Completion Date: August 2011
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: New Zealand, United States
• Removed Location Countries: Australia, Canada, Colombia

Administrative Information

• NCT Number: NCT00765726
• Other Study ID Numbers: 3082B2-4418; B1831003
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: December 2011