At a glance
ClinicalIndex Comparison RecordN/ACompleted· 26 enrolled
Drug / intervention
Idursulfasebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study evaluating Idursulfase for Hunter Syndrome. Completed, enrolled 26 participants across 6 sites in 3 countries.
Detailed 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).
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHunter Syndrome
CountriesBrazil, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
First PostedApr 2009
Primary CompletionFeb 2013
TodayJul 2026
First PostedApr 17, 2009
Enrollment StartOct 14, 2008
Primary CompletionFeb 8, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 17.2 years ago
Interventions
Idursulfasebiological
Patients received idursulfase as prescribed by their physician following locally approved prescribing information. Patients will not be provided idursulfase by Shire Human Genetic Therapies, Inc. or the HOS.