Study Evaluating The Safety Of Xyntha In Usual Care Settings
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemophilia A
Intervention: Moroctocog alfa(AF-CC) (Biological); Blood draw for laboratory testing (Procedure)
Phase: Phase 4
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: A Postauthorization Safety Surveillance Study Of Xyntha In Usual Care Settings
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants With Factor VIII (FVIII) Inhibitor Development
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
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Male.
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.
Locations and Contacts
Pfizer Investigational Site, Christchurch 8001, New Zealand
Pfizer Investigational Site, Los Angeles, California 90007, United States
Pfizer Investigational Site, Washington, District of Columbia 20010, United States
Pfizer Investigational Site, Detroit, Michigan 48202, United States
Pfizer Investigational Site, East Lansing, Michigan 48823, United States
Pfizer Investigational Site, Dayton, Ohio 45404-1815, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: February 2009
Last updated: December 16, 2011
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