Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-19

Study Completion Date

2020-05-10

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.

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Detailed Description

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Conditions

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Hunter Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Elaprase

Participants with Hunter syndrome (Mucopolysaccharydosis II) being treated with Elaprase will be evaluated for this study.

No interventions assigned to this group

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No