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

NCT ID: NCT05155488

Last Updated: 2022-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-06

Study Completion Date

2022-02-15

Brief Summary

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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.

Detailed Description

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Conditions

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Mucopolysaccharidosis (MPS)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants With MPS II

Retrospective data of participants diagnosed with MPS II will be collected from the database (DATASUS) from January 1st, 2008 to September 30th, 2020 in this observational study.

No Intervention

Intervention Type OTHER

This is a non-interventional study.

Interventions

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No Intervention

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Takeda Distribuidora Ltda

São Paulo, , Brazil

Site Status

Countries

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Brazil

Related Links

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https://clinicaltrials.takeda.com/study-detail/61b7bf0df571d4002a64b48c

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

Other Identifiers

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MACS-2021-021601

Identifier Type: OTHER

Identifier Source: secondary_id

TAK-765-5001

Identifier Type: -

Identifier Source: org_study_id

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