Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)

Shire

Status: Completed

Conditions: Hunter Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT03582449

SHP ELA-701

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

5 participants in 1 patient group

Elaprase

Description:

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