A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin (SkyPASS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50672
• EU PAS number:
  EUPAS50671
• Study ID:
  50672
• Official title and acronym:
  A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin (SkyPASS)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  United States
• Study description:
  The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Ascendis Pharma

Endocrinology Division

Study timelines

Date when funding contract was signed

Planned: 02/01/2023

Study start date

Planned: 29/09/2023

Actual: 20/03/2023

Date of final study report

Planned: 29/09/2034

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Ascendis Pharma Endocrinology Division A/S

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)