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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03582449
Other study ID # SHP ELA-701
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT00630747 - Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase Phase 2/Phase 3
Completed NCT03292887 - Hunter Outcome Survey (HOS)
Active, not recruiting NCT02455622 - Long-term Evaluation on Height and Weight in Patients With MPS II Who Started Treatment at < 6 Years of Age Phase 4
Completed NCT00882921 - An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients
Completed NCT00920647 - A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase® Phase 1/Phase 2
Completed NCT01449240 - Collection and Study of Cerebrospinal Fluid in Patients With Hunter Syndrome
Completed NCT03920540 - A Study of GC1111 in Hunter Syndrom Patients Phase 3
Recruiting NCT06031259 - Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment Phase 2/Phase 3
Completed NCT02055118 - Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment Phase 2/Phase 3
Completed NCT01645189 - Safety and Efficacy of Hunterase Phase 3
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Recruiting NCT02044692 - The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients N/A
Completed NCT01822184 - Observational Study to Evaluate Neurodevelopmental Status in Pediatric Patients With Hunter Syndrome (MPS II)
Recruiting NCT05494593 - A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II) Phase 4
Completed NCT00607386 - Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy Phase 4
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Terminated NCT01330277 - Biomarkers for Hunter Syndrome
Completed NCT01506141 - An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment Phase 1/Phase 2