Status:
TERMINATED
Study Evaluating The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Hemophilia A
Eligibility:
MALE
Up to 5 years
Phase:
PHASE3
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 ...
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00759655
Start Date
June 1 2009
End Date
December 1 2009
Last Update
June 15 2022
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