Status:
COMPLETED
Study of rhASB in Patients With Mucopolysaccharidosis VI
Lead Sponsor:
BioMarin Pharmaceutical
Conditions:
Mucopolysaccharidosis VI
Eligibility:
All Genders
7+ years
Phase:
PHASE3
Brief 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
Inclusion
- 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
- 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 assessments
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00104234
Start Date
February 1 2004
End Date
October 1 2006
Last Update
February 2 2010
Active Locations (1)
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1
BioMarin Pharmaceutical Inc.
Novato, California, United States, 94949