At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 4 enrolled
Drug / intervention
Naglazymedrug
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 Phase 4 Multi-center, Multi-national, Open-label, Randomized, Two Dose Level Study of Naglazyme(TM) (Galsulfase) in Infants With Maroteaux-Lamy Syndrome (MPS VI)
In Brief
A Phase 4 clinical trial evaluating Naglazyme for Mucopolysaccharidosis VI and Maroteaux-Lamy Syndrome. Completed, enrolled 4 participants across 4 sites in 3 countries.
Detailed Summary
The purpose of the study is to evaluate the safety and efficacy of two dose levels of Naglazyme in infants under the age of one year who have MPS VI by monitoring physical appearance, x-ray of the skeletal system and growth.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMucopolysaccharidosis VI, Maroteaux-Lamy Syndrome
CountriesFrance, Portugal, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2006
Enrollment StartMay 2006
Primary CompletionApr 2009
TodayJul 2026
First PostedMar 6, 2006
Enrollment StartMay 1, 2006
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.3 years ago
Interventions
Naglazymedrug
Weekly infusion for minimum of 52 weeks. Naglazyme is diluted in sterile 0.9% sodium chloride solution