Study Evaluating The Safety Of Xyntha In Usual Care Settings
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
12 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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