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.
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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