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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00104234 |
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Date of registration:
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24/02/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of rhASB in Patients With Mucopolysaccharidosis VI
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Scientific title:
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A Multicenter, Multinational Open-Label Extension Study of Recombinant Human N-acetylgalactosamine 4-sulfatase (rhASB) in Patients With Mucopolysaccharidosis VI |
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Date of first enrolment:
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February 2004 |
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Target sample size:
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39 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00104234 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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 assessments
Age minimum:
7 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Mucopolysaccharidosis VI
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Intervention(s)
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Drug: N-acetylgalactosamine 4-sulfatase
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Drug: Placebo/rhASB
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Primary Outcome(s)
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12-Minute Walk Test
[Time Frame: Baseline of ASB-03-05 through week 96 of ASB-03-06]
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Secondary Outcome(s)
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3-Minute Stair Climb
[Time Frame: Baseline ASB-03-05 through week 96 of ASB-03-06.]
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Change in Urinary Glycosaminoglycans (GAG) Level
[Time Frame: 72 weeks]
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Secondary ID(s)
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ASB-03-06
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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