Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)

Hunter Syndrome Clinical Trial

Official title:

Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03582449
• Other study ID #: SHP ELA-701
• Status: Completed
• Start date: January 19, 2018
• Est. completion date: May 10, 2020

Study information

• Verified date: September 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 10, 2020
• Est. primary completion date: May 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hunter Syndrome
• Mucopolysaccharidosis II

Locations

Country	Name	City	State
Mexico	Hospital Centenario Miguel Hidalgo	Aguascalientes
Mexico	Hospital Infantil Federico Gomez	Ciudad de México
Mexico	Hospital Universitario de Colima	Colima
Mexico	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

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Change From Baseline in Height Over One Year Study Period	Change in height over one year study period will be assessed.	Baseline, 12 months
Primary	Change From Baseline in Weight Over One Year Study Period	Change in weight over one year study period will be assessed.	Baseline, 12 months

External Links

•   To obtain more information on the study, click here/on this link