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

Wyeth

Status and phase: Terminated; Phase 3

Conditions: Hemophilia A

Treatments: Biological: Moroctocog alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00759655

3082B2-3315-WW

B1831002 (Other Identifier)

3082B2-3315

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: Male

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

open label

Other group

Treatment:

Biological: Moroctocog alfa