Study Evaluating The Safety Of Xyntha In Usual Care Settings

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NCT00765726

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Study Location
Pfizer Investigational Site
Los Angeles, California, 90007, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating The Safety Of Xyntha In Usual Care Settings
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hemophilia A
Intervention  ICMJE
  • 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  ICMJE Moroctocog alfa(AF-CC)
Interventions:
  • Biological: Moroctocog alfa(AF-CC)
  • Procedure: Blood draw for laboratory testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 10, 2011)		12
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2008)		250
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE New Zealand,   United States
Removed Location Countries Australia,   Canada,   Colombia
 
Administrative Information
NCT Number  ICMJE NCT00765726
Other Study ID Numbers  ICMJE 3082B2-4418
B1831003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP