CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 39 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age ≥7 years
  • ✓Documented biochemical or genetic proof of MPS VI
  • ✓Able to walk independently 5–270 meters in 6 minutes, or ≤400 meters in 12 minutes (12-minute walk test)
  • ✓Negative pregnancy test if female of childbearing potential
Key exclusion· 7
  • ✕Under consideration for or has undergone successful bone marrow transplant (BMT)
  • ✕Prior treatment with rhASB
  • ✕Investigational drug within 30 days prior to enrollment
  • ✕Clinically significant spinal cord compression

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00067470
NCT00067470Phase 3Completed
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Study of Recombinant Human N-acetylgalactosamine 4-sulfatase (rhASB) in Patients With MPS VI

BioMarin Pharmaceutical·interventional·Posted Aug 25, 2003·Updated Dec 24, 2009

In Brief

A Phase 3 clinical trial evaluating Placebo and N-acetylgalactosamine 4-sulfatase for Mucopolysaccharidosis VI. Completed, enrolled 39 participants across 1 site.

Detailed Summary

The purpose of the study is to evaluate the ability of rhASB versus placebo to enhance endurance in patients with Mucopolysaccharidosis VI (MPS VI), as evidenced by an increase in the number of meters walked in the 12 minute walk test at Week 24 compared with baseline.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMucopolysaccharidosis VI
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 25, 2003
Enrollment StartSep 1, 2003
Study CompletionMar 1, 2004
TodayJul 2, 2026
Posted 22.9 years ago

Interventions

Placebodrug

N-acetylgalactosamine 4-sulfatasedrug