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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Percentage of Participants With Factor VIII (FVIII) Inhibitor Development
Condition
Hemophilia A
Intervention
Moroctocog alfa(AF-CC)
Study Arms / Comparison Groups
Moroctocog alfa(AF-CC)
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
12
Start Date
February 2009
Completion Date
August 2011
Primary Completion Date
July 2011
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.
Gender
Male
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
New Zealand
Location Countries
New Zealand
Administrative Informations
NCT ID
NCT00765726
Organization ID
3082B2-4418
Secondary IDs
B1831003
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
December 2011