Pfizer Registry of Outcomes in Growth Hormone RESearch (PROGRES) 2.0: A multi-country non-interventional, observational, prospective cohort study among participants treated with human growth hormone (hGH) treatments Genotropin (somatropin) and Ngenla (somatrogon) under routine clinical care.

Study identification

• EU PAS number:
  EUPAS1000000705
• Study ID:
  1000000705
• Official title and acronym:
  Pfizer Registry of Outcomes in Growth Hormone RESearch (PROGRES) 2.0: A multi-country non-interventional, observational, prospective cohort study among participants treated with human growth hormone (hGH) treatments Genotropin (somatropin) and Ngenla (somatrogon) under routine clinical care.
• DARWIN EU® study:
  No
• Study countries:
  Armenia

  Belgium

  Brazil

  Bulgaria

  China

  Czechia

  France

  Georgia

  Germany

  Hong Kong

  Italy

  Malaysia

  Poland

  Portugal

  Saudi Arabia

  Slovenia

  Sri Lanka

  United Kingdom

  United States
• Study description:
  PROGRES 2.0 is a multi-country, non-interventional, observational cohort study; conducted voluntarily by Pfizer to assess the long-term effectiveness and safety of both a; daily hGH Genotropin (somatropin) and a long-acting hGH Ngenla (somatrogon), at the; discretion of the treating physician according to routine clinical care in a real-world setting.; This study will gather the data as a sub-study of the Global Registry for Novel Therapies in; Rare Bone and Endocrine Conditions (GloBE-Reg). Participants can be located anywhere in the world and will be followed for up to 10 years.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Planned:21/05/2025

Actual:21/05/2025

Study start date

Planned:30/09/2025

Actual:03/10/2025

Date of final study report

Planned:28/02/2036

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable