Study Evaluating the Efficacy and Safety of Xyntha™ in Children Less Than 6 Years of Age - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00759655

Purpose

This study will be investigating the safety and efficacy of Xyntha™ (moroctocog alfa (AF-CC)) in male patients less than 6 years old. Annualized bleeding rates and physician caregiver assessments of responses to treatment will be characterized. FVIII inhibitor levels will be assessed throughout the study.

Condition	Intervention	Phase
Hemophilia A	Drug: Moroctocog alfa (AF-CC) Treatment Procedure: Blood draw for laboratory testing	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study to Evaluate the Efficacy and Safety of Xyntha™ in Children Less Than 6 Years of Age in Usual Care Settings

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Caregivers Hemophilia

Drug Information available for: Octocog alfa Moroctocog Alfa Factor VIII

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Inhibitor Development [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Annualized bleeding rates and response to treatment as assessed by the physician and caregiver [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Moroctocog alfa (AF-CC): Experimental	Drug: Moroctocog alfa (AF-CC) Treatment Procedure: Blood draw for laboratory testing

Eligibility

Ages Eligible for Study:	up to 5 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Male patients less than 6 years of age with moderately severe to severe hemophilia A (FVIII less than or equal to 2%)
Treatment history of less than 50 exposure days to prior recombinant or plasma-derived FVIII replacement products
Not receiving treatment for HIV or hepatitis infection, or the patient is on a stable antiviral regimen at the time of enrollment in the study.

Main Exclusion Criteria:

Presence of any bleeding disorder in addition to hemophilia A
Inhibitor titer of greater than or equal to 5 Bethesda Units (BU) at screening
Treated with immunomodulatory therapy during the screening period
Treatment history of more than 5 exposure days (ED) to Xyntha™
Known hypersensitivity to hamster protein

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759655

Locations

United States, Connecticut

Hartford, Connecticut, United States, 06106
United States, District of Columbia

Washington, District of Columbia, United States, 20010
United States, Illinois

Chicago, Illinois, United States, 60614
United States, Indiana

Indianapolis, Indiana, United States, 46260
United States, New Jersey

New Brunswick, New Jersey, United States, 088903-0019
United States, North Carolina

Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3082B2-3315
Study First Received:	September 23, 2008
Last Updated:	September 4, 2009
ClinicalTrials.gov Identifier:	NCT00759655 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

hemophilia A
Xyntha™
ReFacto
moroctocog alfa
bleeding disorder

Study placed in the following topic categories:

Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Blood Coagulation Disorders

Hemophilia A
Hemostatic Disorders
Hemorrhage
Factor VIII

Additional relevant MeSH terms:

Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Coagulants
Genetic Diseases, Inborn
Coagulation Protein Disorders
Hematologic Diseases

Therapeutic Uses
Blood Coagulation Disorders
Hematologic Agents
Hemophilia A
Pharmacologic Actions
Factor VIII

ClinicalTrials.gov processed this record on September 11, 2009