Last updated: 10/06/2020 07:50:05

A study to test the possibility of cross reaction induced by the idursulfase drug to GSK2788723

GSK study ID
116406
See study documents
Clinicaltrials.gov ID
NCT01602601
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Level and capability of binding and neutralizing antibodies induced by idursulfase after the administration of idursulfase

Timeframe: 1 Day

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Idursulfase
  • Drug: GSK2788723
    • Enrollment:
    10
    Primary completion date:
    2012-11-06
    Observational study model:
    Case-Only
    Time perspective:
    Cross-Sectional
    Clinical publications:
    Not applicable
    Medical condition
    Mucopolysaccharidosis II
    Product
    GSK2788723
    Collaborators
    Not applicable
    Study date(s)
    April 2012 to June 2012
    Type
    Observational
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • A subject will be eligible for inclusion in this study only if patient meets criteria 1 and 2
    • or 1 and 3:
    • Subjects who are currently participating in another clinical trial are not permitted to be
    • enrolled in this study.
    Inclusion and exclusion criteria
    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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 157-8535
    Status
    Study Complete
    Contact us

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study 116406 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
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