MPS VI Clinical Surveillance Program (CSP)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38956
• EU PAS number:
  EUPAS19286
• Study ID:
  38956
• Official title and acronym:
  MPS VI Clinical Surveillance Program (CSP)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  France

  Germany

  Ireland

  Lithuania

  Netherlands

  Norway

  Portugal

  Sweden

  United Kingdom

  United States
• Study description:
  The Mucopolysaccharidosis VI (MPS VI) Clinical Surveillance Program (CSP) is being conducted in accordance with post-marketing commitments to the United States (US) Food and Drug Administration (FDA) and European Union (EU) European Medicines Agency (EMA) for Naglazyme. The data collected by this program will provide information to better characterize the natural history and progression of MPS VI in both treated and untreated patients. Data from periodic patient assessments, which are part of a patient’s normal care, may be collected to provide long-term efficacy and safety data.
• Study status:
  Ongoing

Research institutions and networks

Institutions

BioMarin Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 01/07/2005

Actual: 01/07/2005

Study start date

Planned: 12/09/2005

Actual: 12/09/2005

Date of final study report

Planned: 01/07/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

BioMarin International Limited

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)