Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)

Study Overview
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Brief Summary
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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.

Official Title
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Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)

Conditions
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Hunter Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants of both genders Participants to whom idursulfase (Elaprase) has been prescribed Participants with Hunter syndrome Participants accepting to participate Participants signing the informed consent and privacy notice for handling personal information in: the program Contigo Shire (training, diagnosis, family trees) and the intensive pharmacovigilance study for Elaprase. If the participant is unable to provide legal consent (example: under legal age), the participant's legal guardian must provide consent Exclusion Criteria: Participants withdrawing their consent to continue participating in the non-intervention intensive pharmacovigilance study for Elaprase Known hypersensitivity or presence of any contraindication to Elaprase that cannot be controlled by pre-medication A physical condition that would not permit intravenous administration of enzyme replacement therapy (ERT) Participants enrolled in Shire sponsored Elaprase Registry or any other Shire sponsored Elaprase study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elaprase<br>Participants with Hunter syndrome (Mucopolysaccharydosis II) being treated with Elaprase will be evaluated for this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hunter syndrome (Mucopolysaccharydosis II)