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An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients | Clinical Trials | Clareo Health

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An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients

A Multi-Center Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients Enrolled in the Hunter Outcome Survey (HOS) Receiving Idursulfase Enzyme Replacement Therapy

NCT00882921•Shire

View on ClinicalTrials.gov

Summary

The objective of this study is to evaluate the effect of anti-idursulfase antibodies on idursulfase safety (measured by infusion related adverse events) between patients who develop anti-idursulfase antibodies and patients who do not after long-term idursulfase enzyme replacement therapy (ERT).

Detailed Description

This study is being conducted to satisfy post-marketing commitments to monitor anti-idursulfase antibody development in Hunter syndrome patients after long-term idursulfase enzyme replacement therapy. The study will be conducted as a sub-study within the Hunter Outcome Survey (HOS). Hunter syndrome patients in the HOS who have previously received idursulfase as well as treatment-naive patients who will begin idursulfase treatment within 30 days of study enrollment will be included.

Eligibility

Age

5 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Patients must meet all of the following criteria to be considered eligible for enrollment:
•The patient is male and enrolled in the HOS (i.e., meets the entry criteria of a documented diagnosis of Hunter syndrome)
•The patient is ≥ 5 years-old
•The patient is on idursulfase treatment or scheduled to begin idursulfase treatment within 30 days of study enrollment
•The patient, patient's parent(s), or patient's legally authorized guardian must have voluntarily signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient, patient's parent(s), or patient's legally authorized guardian.

Exclusion Criteria

•The patient has received biologic/ERT products other than idursulfase, or other investigational product(s) for any reason within 30 days prior to study entry.
•The patient has a life expectancy of \< 2 years
•The patient is unable to comply with the protocol, e.g., has a clinically relevant medical condition making implementation of the protocol difficult; has an uncooperative attitude; is unable to return for safety evaluations; or is otherwise unlikely to complete the study, as determined by the Investigator.

Locations (6)

Children's Hospital & Research Center Oakland

Oakland, California, United States

Children's Hospitals and Clinics of Minnesota, Division of Genetics

Minneapolis, Minnesota, United States

Hospital de Clinicas de Porto Alegre, Servico de Genetica Medica

Porto Alegre, Rio Grande do Sul, Brazil

Birmingham Children's Hospital

Birmingham, United Kingdom

Great Ormond Street Hospital

London, United Kingdom

Central Manchester University Hospitals, St. Mary's Hospital

Manchester, United Kingdom

Key Dates

Start Date

October 14, 2008

Primary Completion Date

February 8, 2013

Completion Date

February 8, 2013

Last Updated

June 8, 2021

Enrollment

ACTUAL participants

Conditions

Hunter Syndrome

Interventions

Idursulfase

BIOLOGICAL

A Study to Evaluate the Safety, Tolerability, PK and PD of Intracerebroventricular GC1123 in Patients with MPS Ⅱ

NCT05422482

Mucopolysaccharidosis IIHunter Syndrome

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COMPLETEDPHASE2/PHASE3

Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094

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Hunter Syndrome

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety, Tolerability, PK and PD of Intracerebroventricular GC1123 in Patients with MPS Ⅱ

Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094

Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome

Phase I/II Pilot Study of Mixed Chimerism to Treat Inherited Metabolic Disorders

Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment

Allogeneic Bone Marrow Transplant for Inherited Metabolic Disorders