Immunophenotyping of Patients With MPS II Treated With Enzyme Replacement Therapy

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
View:

• 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.

Locations
United States
North Carolina
Duke University
Recruiting
Durham
Contact Information
Primary
Lauren Workman
lauren.workman@duke.edu
919 660-0758
Backup
Ankit Desai, MD
ankit.desai@duke.edu
919-613-6310
Time Frame
Start Date: April 1, 2022
Estimated Completion Date: July 31, 2023
Participants
Target number of participants: 25
Treatments
Treatment Naive
subjects who are naïve to ERT and start treatment with idursulfase
Treatment less than 3 years
Subjects who have received ERT for <3 years
Treatment over 3 years
Subjects who have received ERT for 3 or more years
Sponsors
Leads: Duke University

This content was sourced from clinicaltrials.gov

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