Mucopolysaccharidosis (MPS) Clinical Trial
Official title:
Mucopolysaccharidosis Type II in Brazil: A Retrospective Secondary Database Study (Informatics Department of Brazilian Health System - DATASUS)
| Verified date | May 2022 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Takeda Distribuidora Ltda | São Paulo |
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
Brazil,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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