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Study Evaluating The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age

Last updated on May 10, 2018

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Study Location
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
0-5
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

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

- 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.

NCT00759655
Pfizer
Terminated
Study Evaluating The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age

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Study Evaluating The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age
An Open-Label Study To Evaluate The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age In Usual Care Settings
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.
The study was terminated on 22 Sept 2009 due to competition with another Wyeth study for a similar patient population. The decision to terminate the trial was not based on any safety issues.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hemophilia A
Biological: Moroctocog alfa
Patients will receive Moroctocog alfa according to their investigator's prescription.
open label
Intervention: Biological: Moroctocog alfa
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
December 2009
December 2009   (Final data collection date for primary outcome measure)

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.

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.
Sexes Eligible for Study: Male
up to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00759655
3082B2-3315
B1831002 ( Other Identifier: Pfizer )
3082B2-3315-WW
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 2011

ICMJE     Data element required by the

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

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