At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 39 enrolled
Drug / intervention
N-acetylgalactosamine 4-sulfatase +1 moredrug
Likely dose
Not stated in record
Key inclusion· 2
- ✓Patient must have successfully completed study ASB-03-05, including having received at least 20 of 24 scheduled weekly infusions and having missed no more than two consecutive infusions
- ✓Female of childbearing potential must have negative pregnancy test
Key exclusion· 3
- ✕Pregnant or lactating patient
- ✕Received an investigational drug within 30 days prior to enrollment
- ✕Unwilling or unable to travel to the primary site for periodic assessments
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Multinational Open-Label Extension Study of Recombinant Human N-acetylgalactosamine 4-sulfatase (rhASB) in Patients With Mucopolysaccharidosis VI
In Brief
A Phase 3 clinical trial evaluating N-acetylgalactosamine 4-sulfatase and Placebo/rhASB for Mucopolysaccharidosis VI. Completed, enrolled 39 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the long-term efficacy and safety of rhASB treatment in patients with Mucopolysaccharidosis VI.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMucopolysaccharidosis VI
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2004
First PostedFeb 2005
Primary CompletionOct 2006
TodayJul 2026
First PostedFeb 25, 2005
Enrollment StartFeb 1, 2004
Primary CompletionOct 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 21.4 years ago
Interventions
N-acetylgalactosamine 4-sulfatasedrug
Placebo/rhASBdrug