This extension study will allow participants that completed Study HGT-HIT-094 to continue receiving Elaprase treatment in conjunction with idursulfase IT or to continue receiving Elaprase treatment and begin concurrent IT treatment for those that did not receive idursulfase IT treatment in Study HGT-HIT-094.
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Number of Participants With Adverse Events (AEs)
Timeframe: Up to 9 years
Number of Participants With Clinically Significant Changes in Vital Signs
Timeframe: Up to 9 years
Number of Participants With Clinically Significant Changes in Laboratory Parameters
Timeframe: Up to 9 years
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Findings
Timeframe: Up to 9 years
Maximum Observed Serum Concentration (Cmax) of Idursulfase
Timeframe: Predose and at 30 min, 60 min, 120 min, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 30 hours and 36 hours post-dose at Week 100 in relation to HGT-HIT-094 (Week 48 of this study)
Percent Change From Baseline in the Concentration of Glycosaminoglycan (GAG) in CSF at Month 67
Timeframe: For participants who began IT treatment in HGT-HIT-094: From Baseline of HGT-HIT-094 up to Month 67 in relation to HGT-HIT-094; For participants who began IT treatment in this study: From Baseline of this study up to Month 55 of this study.
Percent Change From Baseline in the Concentration of GAG in Urine at Month 67
Timeframe: For participants who began IT treatment in HGT-HIT-094: From Baseline of HGT-HIT-094 up to Month 67 in relation to HGT-HIT-094; For participants who began IT treatment in this study: From Baseline of this study up to Month 55 of this study.
Number of Participants Who Reported Positive for Anti-idursulfase Antibodies in CSF
Timeframe: Up to 9 years
Number of Participants Who Reported Positive for Anti-idursulfase Antibodies in Serum
Timeframe: Up to 9 years