5 and older, male only, with Hunter Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Infusion-Related Adverse Event (IRAE) Rates Between IgG Anti-idursulfase Antibody Positive (Ab+) and Anti-idursulfase IgG Antibody Negative (Ab-) PatientsPrimary· Baseline to 109 Weeks
The primary analysis of how presence of antibodies affected IRAE rates was performed based on a negative binomial regression model. This was done to account for potentially differential follow-up time between antibody groups.
Ab+ (n =13)
Group
Value
95% CI
Idursulfase (Elaprase) 0.5 mg/kg Weekly
0.0121
Ab- (n = 13)
Group
Value
95% CI
Idursulfase (Elaprase) 0.5 mg/kg Weekly
0.0042
Ab+ (age adjusted)(n = 13)
Group
Value
95% CI
Idursulfase (Elaprase) 0.5 mg/kg Weekly
0.0055
Ab- (age adjusted)(n = 13)
Group
Value
95% CI
Idursulfase (Elaprase) 0.5 mg/kg Weekly
0.0026
Change From Baseline in uGAG Levels to 109 WeeksSecondary· Baseline to 109 Weeks
Urine GAG
Group
Value
95% CI
Elaprase
-74.07
± 246.663
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The objective of this study is to evaluate the effect of anti-idursulfase antibodies on idursulfase safety (measured by infusion related adverse events) between patients who develop anti-idursulfase antibodies and patients who do not after long-term idursulfase enzyme replacement therapy (ERT).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04573023 — A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)
· Phase 3
· active not recruiting
NCT01602601 — A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723
· completed
NCT00607386 — Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy
· Phase 4
· completed
NCT00630747 — Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase
· Phase 2, PHASE3
· completed
Other recruiting trials for Hunter Syndrome
Currently open trials in the same condition.
NCT06031259 — Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairme
· Phase 2, PHASE3
· active not recruiting
NCT02171104 — MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
· Phase 2
· active not recruiting
Other Shire trials
Trials by the same sponsor.
NCT05067868 — A Study of Replagal in Children and Adults With Fabry Disease in India
· Phase 4
· recruiting
NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism
· Phase 3
· withdrawn
NCT04840667 — A Study of Replagal in Treatment-naïve Adults With Fabry Disease
· Phase 3
· terminated
NCT04429984 — Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India
· completed
NCT04440488 — ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study
· Phase 4
· withdrawn
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shire
Last refreshed: 8 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00882921.