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Open-Label Study of Efficacy and Safety of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients With MPS VI

NCT00048711 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2009-08-25

No results posted yet for this study

Summary

The purpose of the study is evaluate the efficacy, safety, and pharmacokinetics of weekly intravenous infusions of 1 mg/kg recombinant human N-acetylgalactosamine 4-sulfatase (rhASB) in patients diagnosed with Mucopolysaccharidosis VI (MPS VI)

Conditions

  • Mucopolysaccharidosis VI

Interventions

DRUG

N-acetylgalactosamine 4-sulfatase

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Completion
2006-06-30

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 NCT00048711 on ClinicalTrials.gov