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A Study to Improve the Awareness of Mucopolysaccharidosis Type II in Brazil

Mucopolysaccharidosis Type II in Brazil: A Retrospective Secondary Database Study (Informatics Department of Brazilian Health System - DATASUS)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05155488
Enrollment
250
Registered
2021-12-13
Start date
2021-12-06
Completion date
2022-02-15
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucopolysaccharidosis (MPS)

Brief summary

The main aims of the study are to learn about the percentage of mucopolysaccharidosis type II (MPS II) in adults in Brazil as well as about the diagnosis process. No study medicines will be provided to participants in this study. The data available for participants diagnosed with MPS II in DATASUS (a database of the Informatics Department of Brazilian Health System) will be reviewed. No clinic visits will be required as part of participation in this study.

Interventions

OTHERNo Intervention

This is a non-interventional study.

Sponsors

Takeda
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

All MPS II cases of (International Classification of Diseases, 10th revision \[ICD-10\] E76.1) at any age reported in DATASUS from January 1st, 2008 to September 30th, 2020 will be included.

Exclusion criteria

MPS II cases reported outside this period will be excluded.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Diagnosed With MPS IIFrom January 1, 2008 to September 30, 2020Number of participants diagnosed with MPS II will be reported based on the retrospective data of participants collected from the database (DATASUS).
Number of Participants with Comorbidities Associated with MPS IIFrom January 1, 2008 to September 30, 2020Comorbidities will be like respiratory infections, carpal tunnel syndrome and hernia. Number of participants with comorbidities associated with MPSII will be reported based on the retrospective data of participants collected from the database (DATASUS).
Age of MPS II DiagnosisFrom January 1, 2008 to September 30, 2020Age of MPS II diagnosis will be calculated from the date of birth and date of diagnosis. Retrospective data of participants will be collected from the database (DATASUS).

Secondary

MeasureTime frameDescription
Time Between MPS Diagnosis II and Start of TreatmentFrom January 1, 2008 to September 30, 2020Time between MPS diagnosis II and start of treatment will be reported based on the retrospective data of participants collected from the database (DATASUS).
Number of Health Care Professionals Who Diagnosed MPS IIFrom January 1, 2008 to September 30, 2020Number of health care professionals who diagnosed the MPS II will be reported based on the retrospective data of participants collected from the database (DATASUS).
Number of Treatments Received Before and After MPS II DiagnosisFrom January 1, 2008 to September 30, 2020Number of treatments received by participant before and after MPS II diagnosis will be reported based on the retrospective data of participants collected from the database (DATASUS).
Number of Health Care Professionals ConsultedFrom January 1, 2008 to September 30, 2020Number of health care professionals consulted before MPS II diagnosis will be reported based on the retrospective data of participants collected from the database (DATASUS).
Time to MPS II DiagnosesFrom January 1, 2008 to September 30, 2020Time between first Unified Health System (a Brazilian Health System) consultation and MPS II diagnosis will be reported based on the retrospective data of participants collected from the database (DATASUS).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026