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Study Evaluating The Safety Of Xyntha In Usual Care Settings

Last updated on December 16, 2017

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Study Location
Pfizer Investigational Site
Los Angeles, California, 90007 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00765726
Pfizer
Terminated
Study Evaluating The Safety Of Xyntha In Usual Care Settings

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Study Evaluating The Safety Of Xyntha In Usual Care Settings
A Postauthorization Safety Surveillance Study Of Xyntha In Usual Care Settings
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.

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.

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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
August 2011
July 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
New Zealand,   United States
Australia,   Canada,   Colombia
 
NCT00765726
3082B2-4418
B1831003
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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