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Study Evaluating The Safety Of Xyntha In Usual Care Settings

Primary Purpose

Hemophilia A

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Moroctocog alfa(AF-CC)
Blood draw for laboratory testing
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia A focused on measuring hemophilia, hemophilia A, ReFacto, Xyntha, moroctocog alfa, bleeding disorder

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Moroctocog alfa(AF-CC)

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Factor VIII (FVIII) Inhibitor Development
FVIII inhibitor development was defined as an inhibitor titer of more than or equal to 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay and confirmed by the central laboratory.

Secondary Outcome Measures

Full Information

First Posted
October 2, 2008
Last Updated
December 16, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00765726
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A
Keywords
hemophilia, hemophilia A, ReFacto, Xyntha, moroctocog alfa, bleeding disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moroctocog alfa(AF-CC)
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Moroctocog alfa(AF-CC)
Other Intervention Name(s)
Xyntha
Intervention Description
Dosing is at the discretion of the investigator during the study
Intervention Type
Procedure
Intervention Name(s)
Blood draw for laboratory testing
Intervention Description
Hematology and Chemistry panels, Factor VIII inhibitor and recovery studies
Primary Outcome Measure Information:
Title
Percentage of Participants With Factor VIII (FVIII) Inhibitor Development
Description
FVIII inhibitor development was defined as an inhibitor titer of more than or equal to 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay and confirmed by the central laboratory.
Time Frame
Month 24 or early withdrawal

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States
Facility Name
Pfizer Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Pfizer Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Pfizer Investigational Site
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
Facility Name
Pfizer Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404-1815
Country
United States
Facility Name
Pfizer Investigational Site
City
Christchurch
ZIP/Postal Code
8001
Country
New Zealand

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3082B2-4418&StudyName=Study%20Evaluating%20The%20Safety%20Of%20Xyntha%20In%20Usual%20Care%20Settings
Description
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Study Evaluating The Safety Of Xyntha In Usual Care Settings

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