A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723
A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723
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
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
Inclusion Criteria:

 A subject will be eligible for inclusion in this study only if patient meets criteria 1 and
 2 or 1 and 3:

 -  Diagnosed with Hunter syndrome

 -  Patients with Hunter syndrome who are being treated with idursulfase

 -  Patients with Hunter syndrome who are naïve of idursulfase treatment (if possible*)
 *This study will also attempt to recruit 1 patient who has never received idursulfase.
 If a naïve patient has not been identified within an agreed amount of time between GSK
 and the investigator, the study will concluded without this sample

 Exclusion Criteria:

 -  Subjects who are currently participating in another clinical trial are not permitted
 to be enrolled in this study.