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

NCT00759655

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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
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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age
Official Title  ICMJE An Open-Label Study To Evaluate The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age In Usual Care Settings
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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
Patients will receive Moroctocog alfa according to their investigator's prescription.
Study Arms  ICMJE open label
Intervention: Biological: Moroctocog alfa
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: October 12, 2009)
1
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2008)
30
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE up to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00759655
Other Study ID Numbers  ICMJE 3082B2-3315
B1831002 ( Other Identifier: Pfizer )
3082B2-3315-WW
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2011

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