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

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ClinicalTrials.gov Identifier: NCT01602601
Recruitment Status : Completed
First Posted : May 21, 2012
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

May 17, 2012
May 21, 2012
September 25, 2017
April 9, 2012
June 11, 2012   (Final data collection date for primary outcome measure)
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
  • 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 ]
Complete list of historical versions of study NCT01602601 on ClinicalTrials.gov Archive Site
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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 of the Antibodies Induced by the ELAPRASE (R) to GSK2788723 ELAPRASE is a Trade Mark Owned by a Third Party
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
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
blood samples will be collected and serum will be analyzed and retained
Probability Sample
Approximately 11 subjects will be enrolled in the study.
Mucopolysaccharidosis II
  • Drug: Idursulfase
    recombinant version of IDS produced from human fibroblast. idursulfase is approved for every week (EW) intravenous (IV) administration.
    Other Name: recombinant IDS
  • Drug: GSK2788723
    GSK2788723 is being developed by JCR and GSK for the treatment of Hunter syndrome
Cohort 1
Patients will have a single blood draw for the analysis of antibodies induced by idursulfase. Samples 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.
Interventions:
  • Drug: Idursulfase
  • Drug: GSK2788723
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
11
June 11, 2012
June 11, 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01602601
116406
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2017