TerminatedNot Applicable

MPS II Immunophenotyping

Stopped: Low Enrollment

United States6 participantsStarted 2022-04-01

Plain-language summary

The purpose of this study is to investigate how participant's body's immune system responds to idursulfase, an enzyme replacement therapy (ERT) and find out which types of immune cells are involved in causing untoward responses to the ERT so that the investigators can relate the level of immune response to the treatment.

Who can participate

SexALL

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Inclusion Criteria: * Subject has a confirmed diagnosis of Mucopolysaccharidosis type II (MPS II) or Hunter Syndrome based on enzyme activity and variant analysis. * Subject who plan to receive or have received enzyme replacement therapy with idursulfase. Exclusion Criteria: * None

What they're measuring

Changes in the frequency of natural killer cells measured by flow cytometry

Timeframe: baseline, 1, 3, 6 months

Changes in level of circulation memory B cells measured by flow cytometry

Timeframe: baseline, 1, 3, 6 months

Changes in level of T follicular helper cells measured by flow cytometry

Timeframe: baseline, 1, 3, 6 months

Changes in distribution of helper T cells measured by flow cytometry

Timeframe: baseline, 1, 3, 6 months

Trial details

NCT IDNCT04976231

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-04-26

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