At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 7 enrolled
Drug / intervention
Laronidase +2 morebiological
Likely dose
Laronidase 0.058 mg/kgfrom 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 Trial of Antigen-specific Immune Tolerance Induction in Mucopolysaccharidosis I (MPS I) Patients Initiating Enzyme Replacement Therapy With Aldurazyme® (Laronidase)
In Brief
A Phase 2 clinical trial evaluating Laronidase, Cyclosporine A (CsA), and 1 other intervention for Mucopolysaccharidosis I. Completed, enrolled 7 participants across 2 sites in 2 countries.
Detailed Summary
The purpose of this study is to see if treatment with an antigen-specific immunosuppressive can decrease or stop an antibody response to laronidase (Aldurazyme®) during enzyme replacement therapy with laronidase in severe Mucopolysaccharidosis I (MPS I) participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMucopolysaccharidosis I
CountriesBrazil, Russia
CollaboratorsBioMarin/Genzyme LLC
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2008
Enrollment StartSep 2008
Primary CompletionSep 2012
TodayJul 2026
First PostedAug 26, 2008
Enrollment StartSep 1, 2008
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 17.8 years ago
Interventions
Laronidasebiological
0.058 mg/kg - 0.58 mg/kg IV infusion weekly.
Cyclosporine A (CsA)drug
Orally three times daily.
Azathioprine (Aza)drug
Orally either every day for Cohort 1 or every other day for Cohort 2.