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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

Page last updated: August 23, 2015

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