MedTrace Logo

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

NCT01602601 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2017-09-25

No results posted yet for this study

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

Conditions

  • Mucopolysaccharidosis II

Interventions

DRUG

Idursulfase

recombinant version of IDS produced from human fibroblast. idursulfase is approved for every week (EW) intravenous (IV) administration.

DRUG

GSK2788723

GSK2788723 is being developed by JCR and GSK for the treatment of Hunter syndrome

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-09
Primary Completion
2012-06-11
Completion
2012-06-11

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01602601 on ClinicalTrials.gov