Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)

Shire5 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hunter Syndrome

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (6)

Hospital Pediátrico de Sinaloa

Culiacán Rosales, México, Mexico

IMSS UMAE 25 (INSTITUTO MEXICANO DEL SEGURO SOCIAL UNIDAD MEDICA DE ALTA ESPECIALIDAD No 25)

Monterrey, Nuevo León, Mexico

Hospital del Niño Tabasqueño

Villahermosa, Tabasco, Mexico

Hospital Centenario Miguel Hidalgo

Aguascalientes, Mexico

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 12 months

Change From Baseline in Weight Over One Year Study Period

Change in weight over one year study period will be assessed.

Time frame: Baseline, 12 months

Data from ClinicalTrials.gov

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