跳至主要内容
临床试验/NCT05155488
NCT05155488已完成不适用

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

Takeda1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
250
试验地点
1
主要终点
Number of Participants with Comorbidities Associated with MPS II

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • MPS II cases reported outside this period will be excluded.

结局指标

主要结局

Number of Participants with Comorbidities Associated with MPS II

时间窗: From January 1, 2008 to September 30, 2020

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).

Number of Participants Diagnosed With MPS II

时间窗: From January 1, 2008 to September 30, 2020

Number of participants diagnosed with MPS II will be reported based on the retrospective data of participants collected from the database (DATASUS).

Age of MPS II Diagnosis

时间窗: From January 1, 2008 to September 30, 2020

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).

次要结局

  • Number of Health Care Professionals Consulted(From January 1, 2008 to September 30, 2020)
  • Number of Health Care Professionals Who Diagnosed MPS II(From January 1, 2008 to September 30, 2020)
  • Number of Treatments Received Before and After MPS II Diagnosis(From January 1, 2008 to September 30, 2020)
  • Time to MPS II Diagnoses(From January 1, 2008 to September 30, 2020)
  • Time Between MPS Diagnosis II and Start of Treatment(From January 1, 2008 to September 30, 2020)

研究者

发起方
Takeda
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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