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Study of Recombinant Human N-Acetylgalactosamine 4-Sulfatase in Patients With MPS VI

NCT00048620 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2006-11-03

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety, efficacy and pharmacokinetics of two dose levels of weekly intravenous infusions of recombinant human N-acetylgalactosamine 4-sulfatase (rhASB) for a minimum of 24 weeks in patients diagnosed with MPS VI.

Conditions

  • Mucopolysaccharidosis VI

Interventions

DRUG

N-acetylgalactosamine 4-sulfatase

Sponsors & Collaborators

Principal Investigators

  • Stuart J Swiedler, MD, Ph.D. · BioMarin Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Completion
2005-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00048620 on ClinicalTrials.gov