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

study id #: NCT05155488

condition: Mucopolysaccharidosis (MPS)

status: Recruiting

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.

intervention: No Intervention

results: https://clinicaltrials.gov/ct2/show/results/NCT05155488

last updated: February 26, 2022

start date: December 6, 2021

estimated completion: March 30, 2022

last updated: January 10, 2022

size / enrollment: 250

primary outcomes:

• 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
  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
  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 outcomes:

• Number of Health Care Professionals Who Diagnosed MPS II
  From January 1, 2008 to September 30, 2020
• Number of Health Care Professionals Consulted
  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
• Number of Treatments Received Before and After MPS II Diagnosis
  From January 1, 2008 to September 30, 2020

inclusion criteria:

exclusion criteria: Criteria:

MPS II cases reported outside this period will be excluded.

sponsor: Takeda

contacts: Takeda Contact, +1-877-825-3327, medinfoUS@takeda.com

investigators: Study Director,Takeda

trial center locations: Brazil

• Brazil
  Takeda Distribuidora Ltda
  Site Contact, +55-11 989850103, ana-cristina.monteiro@takeda.com