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Study of rhASB in Patients With Mucopolysaccharidosis VI

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Trial Status Completed

Trial Identifier

NCT00104234

Condition

MPS VI, Mucopolysaccharidosis VI

The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.

Trial Summary

The purpose of this study is to evaluate the long-term efficacy and safety of rhASB treatment in patients with Mucopolysaccharidosis VI.

Eligibility Criteria

Birth Sex

All

Age

From 7 Years

Healthy Volunteers

No

Drug/Treatment:

N-acetylgalactosamine 4-sulfatase, Placebo/rhASB

Phase:

Phase 3

Study Type:

Interventional

Number of Participants:

39

Study Started:

2004-02

Study Updated:

2010-02-02

Trial Locations

  • BioMarin Pharmaceutical Inc.

    Novato, California, United States

Inclusion Criteria

  • Patient consent
  • 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 then two consecutive infusions
  • If female of childbearing potential, patient must have a negative pregnancy test

Exclusion Criteria

  • Pregnant or lactating patient
  • Patient has received an investigational drug within 30 days prior to study enrollment
  • Patient is unwilling or unable to travel to the primary site for periodic assessment

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