Study Evaluating The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age
NCT00759655
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- 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.
- 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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Descriptive Information | ||||
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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 | 1 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |