A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723
Status:
Completed
Trial end date:
2012-06-11
Target enrollment:
Participant gender:
Summary
Study IDS116406 will be a non-interventional, phlebotomy study in Hunter Syndrome patients
who are currently being treated with idursulfase, an enzyme replacement therapy, and in at
least a single patient who is naïve to treatment, if possible to recruit. All patients
enrolled into the study will have a single blood draw for the analysis of antibodies induced
by this enzyme replacement therapy (idursulfase). Patient samples with positive responses to
antibodies induced by idursulfase will be used to further evaluate whether the antibodies
induced by idursulfase bind to GSK2788723 molecules in vitro and if these antibodies
neutralize the bioactivity of GSK2788723 in vitro. Each subject will have a screening visit,
which may occur at their regularly scheduled out-patient visit. If the patient consents to
participate in the study, a blood sample (total volume of approximately 3mL) for
immunogenicity analysis will be drawn before their current treatment infusion