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

Mucopolysaccharidosis (MPS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05155488
• Other study ID #: TAK-765-5001
• Secondary ID: MACS-2021-021601
• Status: Completed
• Start date: December 6, 2021
• Est. completion date: February 15, 2022

Study information

• Verified date: May 2022
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Mucopolysaccharidoses
• Mucopolysaccharidosis (MPS)
• Mucopolysaccharidosis II

Intervention

Other:
• No Intervention
This is a non-interventional study.

Locations

Country	Name	City	State
Brazil	Takeda Distribuidora Ltda	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Diagnosed With MPS II	Number of participants diagnosed with MPS II will be reported based on the retrospective data of participants collected from the database (DATASUS).	From January 1, 2008 to September 30, 2020
Primary	Number of Participants with Comorbidities Associated with MPS II	Comorbidities 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).	From January 1, 2008 to September 30, 2020
Primary	Age of MPS II Diagnosis	Age 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).	From January 1, 2008 to September 30, 2020
Secondary	Number of Health Care Professionals Who Diagnosed MPS II	Number of health care professionals who diagnosed the MPS II will be reported based on the retrospective data of participants collected from the database (DATASUS).	From January 1, 2008 to September 30, 2020
Secondary	Number of Health Care Professionals Consulted	Number of health care professionals consulted before MPS II diagnosis will be reported based on the retrospective data of participants collected from the database (DATASUS).	From January 1, 2008 to September 30, 2020
Secondary	Time to MPS II Diagnoses	Time 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).	From January 1, 2008 to September 30, 2020
Secondary	Time Between MPS Diagnosis II and Start of Treatment	Time between MPS diagnosis II and start of treatment will be reported based on the retrospective data of participants collected from the database (DATASUS).	From January 1, 2008 to September 30, 2020
Secondary	Number of Treatments Received Before and After MPS II Diagnosis	Number 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).	From January 1, 2008 to September 30, 2020

External Links

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