Clinical Trial: A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Study to Test the Possibility of Cross Reaction of the Antibodies Induced by the ELAPRASE (R) to GSK2788723ELAPRASE is a Trade Mark Owned by a Third Party

Brief 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

Detailed 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
Sponsor: GlaxoSmithKline

Current Primary Outcome: Level and capability of binding and neutralizing antibodies induced by idursulfase after the administration of idursulfase [ Time Frame: 1 Day ]

To assess the cross-reactivity of the antibodies induced by idursulfase to GSK2788723, in vitro


Original Primary Outcome:

  • Level of binding and neutralizing antibodies induced by ELAPRASE (R) after the administration of Elaprase (R) [ Time Frame: 1 Day ]
    To assess the cross-reactivity of the antibodies induced by ELAPRASE (R) to GSK2788723, in vitro
  • Binding and neutralizing capability of antibodies induced by ELAPRASE (R) to GSK2788723 [ Time Frame: 1 Day ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: GlaxoSmithKline

Dates:
Date Received: May 17, 2012
Date Started: April 2012
Date Completion:
Last Updated: May 9, 2013
Last Verified: October 2012