NCT00765726

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2009

Typical duration for phase_4

Geographic Reach
2 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 20, 2012

Completed
Last Updated

January 20, 2012

Status Verified

December 1, 2011

Enrollment Period

2.4 years

First QC Date

October 2, 2008

Results QC Date

December 16, 2011

Last Update Submit

December 16, 2011

Conditions

Hemophilia A

Keywords

hemophiliahemophilia AReFactoXynthamoroctocog alfableeding disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    Month 24 or early withdrawal

Study Arms (1)

Moroctocog alfa(AF-CC)

OTHER
Biological: Moroctocog alfa(AF-CC)Procedure: Blood draw for laboratory testing

Interventions

Moroctocog alfa(AF-CC)BIOLOGICAL

Dosing is at the discretion of the investigator during the study

Also known as: Xyntha
Moroctocog alfa(AF-CC)
Blood draw for laboratory testingPROCEDURE

Hematology and Chemistry panels, Factor VIII inhibitor and recovery studies

Moroctocog alfa(AF-CC)

Eligibility Criteria

Age12 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pfizer Investigational Site

Los Angeles, California, 90007, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20010, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 48202, United States

Location

Pfizer Investigational Site

East Lansing, Michigan, 48823, United States

Location

Pfizer Investigational Site

Dayton, Ohio, 45404-1815, United States

Location

Pfizer Investigational Site

Christchurch, New Zealand, 8001, New Zealand

Location

Related Links

MeSH Terms

Conditions

Hemophilia AHemostatic Disorders

Interventions

F8 protein, humanBlood Specimen Collection

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Limitations and Caveats

The study was discontinued because the sponsor had ongoing studies collecting similar safety data.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2008

First Posted

October 3, 2008

Study Start

February 1, 2009

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

January 20, 2012

Results First Posted

January 20, 2012

Record last verified: 2011-12

Locations

US(5)NZ(1)