Study Evaluating The Safety Of Xyntha In Usual Care Settings

Phase 4

Terminated

• Conditions: Hemophilia A
• Interventions: Biological: Moroctocog alfa(AF-CC); Procedure: Blood draw for laboratory testing

• Registration Number: NCT00765726
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to collect safety information associated with the use of Xyntha in a usual care setting. Upon meeting eligibility criteria, patients will be required to have approximately 5 study visits over a 2 year period. Procedures completed throughout the study include collection of vital signs, physical exams, and laboratory assessments. Patients will be required to complete an infusion log for each Xyntha infusion.

Detailed Description

The study was terminated on May 12, 2011 due to poor enrollment prospects and the study's similarity to another ongoing trial with ReFacto AF.

The termination of this study has no impact on subject safety or well being. The decision to terminate the trial was not based on any safety concerns.

Study Timeline

• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Study Start: 2009-02
• Primary Completion: 2011-07
• Study Completion: 2011-08
• Status Verified: 2011-12
• Results First Submitted: 2011-12-16
• Results First Submitted QC: 2011-12-16
• Last Update Submitted: 2011-12-16
• Results First Posted: 2012-01-20
• Last Update Posted: 2012-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Male patients 12 years of age and older.
• Patients transitioned to Xyntha from other recombinant or plasma-derived FVIII replacement products.
• Treatment history of 150 or greater exposure days to any FVIII products prior to Enrollment visit.
• Negative inhibitor at screening or documentation of negative inhibitor titer within 6 weeks or less prior to study entry except for patients entering the study on immune tolerance induction therapy.

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Exclusion Criteria

• Bleeding disorder other than hemophilia A.
• Inhibitor titer greater than or equal to 0.6 BU during screening except for patients on immune tolerance induction therapy.
• Immunomodulatory therapy during screening period.
• Known hypersensitivity to hamster protein.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Moroctocog alfa(AF-CC)	Moroctocog alfa(AF-CC)	-
Moroctocog alfa(AF-CC)	Blood draw for laboratory testing	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Factor VIII (FVIII) Inhibitor Development	Month 24 or early withdrawal	FVIII inhibitor development was defined as an inhibitor titer of more than or equal to 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay and confirmed by the central laboratory.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇳🇿 Christchurch, New Zealand