The objective of this study is to assess the long-term safety and efficacy of Hunterase for approximately 1 year in subjects who completed the end of study (EOS) visit (Visit 54) tests in the Phase 3 Hunterase study and patients who received Hunterase for more than 6 months
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
0.5mg/kg weekly IV administration
Samsung Medical Center
Seoul, South Korea
Laboratory tests (CBC, Chemistry, Urinanalysis)
Abnormality of Laboratory tests results
Time frame: Every visit until 12months
Physical examination
Abnormality of physical examination
Time frame: Every visit until 12months
Adverse Event
occurence, grade
Time frame: Every visit until 12months
Electrocardiography
Abnormality of ECG results
Time frame: Every 6 months until 12months
6-minute walk test
Mean, Change and percent change of 6-minute walk test
Time frame: Every 4months until 12months
Urine GAG (Heparan sulfate, Dermatan sulfate)
Mean, Change and percent change of Urine HS/DS
Time frame: Every visit until 12months
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