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The purpose of this non-interventional, observational study which is conducted in Mexico is to evaluate the safety profile of elaprase (idulsurfase) in participants with hunter syndrome (mucopolysaccharydosis II) being treated with elaprase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elaprase | Participants with Hunter syndrome (Mucopolysaccharydosis II) being treated with Elaprase will be evaluated for this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events During Administration of Elaprase | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that do not necessarily have a causal relationship with this treatment. Incidence of adverse events during administration of elaprase will be reported. | During 12 months of study participation |
| Incidence of Adverse Events According to the System Organ Class and MedDRA Preferred Term | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that do not necessarily have a causal relationship with this treatment. Incidence of adverse events according to the system organ class and MedDRA preferred term will be reported. | During 12 months of study participation |
| Incidence of Adverse Events 2 months After Early Termination of Elaprase Treatment. | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that do not necessarily have a causal relationship with this treatment. Incidence of adverse events 2 months after early termination of Elaprase treatment will be reported. | 2 months after early termination of Elaprase treatment |
| Change From Baseline in Height Over One Year Study Period | Change in height over one year study period will be assessed. | Baseline, 12 months |
| Change From Baseline in Weight Over One Year Study Period | Change in weight over one year study period will be assessed. | Baseline, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with hunter syndrome (mucopolysaccharydosis II) being treated with elaprase will be evaluated for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Shire Study Physician | Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Pediátrico de Sinaloa | Culiacán Rosales | México | 80200 | Mexico | ||
| IMSS UMAE 25 (INSTITUTO MEXICANO DEL SEGURO SOCIAL UNIDAD MEDICA DE ALTA ESPECIALIDAD No 25) |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual participants could be re-identified (due to the limited number of study participants)
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| ID | Term |
|---|---|
| D016532 | Mucopolysaccharidosis II |
| ID | Term |
|---|---|
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| Monterrey |
| Nuevo León |
| 64180 |
| Mexico |
| Hospital del Niño Tabasqueño | Villahermosa | Tabasco | 86100 | Mexico |
| Hospital Centenario Miguel Hidalgo | Aguascalientes | CP 20000 | Mexico |
| Hospital Universitario de Colima | Colima | 28019 | Mexico |
| Hospital Infantil Federico Gomez | Mexico City | 06720 | Mexico |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D009083 | Mucopolysaccharidoses |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D016464 | Lysosomal Storage Diseases |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |