An Active Surveillance Study to Monitor the Real-World Long-term Safety of Somatrogon Among Paediatric Patients in Europe

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107218
• EU PAS number:
  EUPAS107217
• Study ID:
  107218
• Official title and acronym:
  An Active Surveillance Study to Monitor the Real-World Long-term Safety of Somatrogon Among Paediatric Patients in Europe
• DARWIN EU® study:
  No
• Study countries:
  France

  Spain

  Sweden

  United Kingdom
• Study description:
  The primary purpose of this study will be to assess the long-term safety of somatrogon, a long-acting hGH, under routine clinical care and is intended to reflect outcomes that occur in real-world clinical practice.
• Study status:
  Planned

Research institution and networks

Institutions

Pfizer

Real World Studies, LA-SER Research

France

United Kingdom

IQVIA

United Kingdom

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Cegedim Health Data (CHD)

France

Contact details

Cherise Wong

Study contact

[e-mail]

Kofi Asomaning

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 30/03/2022

Data collection

Planned: 15/06/2024

Date of final study report

Planned: 15/12/2032

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc

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)