Pfizer Registry of Outcomes in Growth hormone RESearch (PROGRES): A multi country, non-interventional prospective cohort study among patients with human growth hormone (hGH) treatments under routine clinical care

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47021
• EU PAS number:
  EUPAS43715
• Study ID:
  47021
• Official title and acronym:
  Pfizer Registry of Outcomes in Growth hormone RESearch (PROGRES): A multi country, non-interventional prospective cohort study among patients with human growth hormone (hGH) treatments under routine clinical care
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Belgium

  Canada

  Czechia

  Denmark

  France

  Germany

  Greece

  Ireland

  Israel

  Italy

  Japan

  Korea, Republic of

  Netherlands

  Portugal

  Slovakia

  Spain

  Sweden

  Switzerland

  Taiwan

  Türkiye

  United Kingdom

  United States
• Study description:
  This is a multi-country, non-interventional, prospective cohort study of patients exposed to Genotropin, other daily hGH treatments, and Ngenla long-acting hGH once it is licensed and commercially available, as prescribed by the treating physician according to routine clinical practices. Patient treatment with a particular therapeutic regimen will be determined at the discretion of the treating physician or other healthcare provider specialties in the countries where this non-interventional study (NIS) is being conducted, under routine clinical care. The study aims to include eligible patients from over 400 participating sites in over 20 countries around the world. Male and female patients of any age meeting the following eligibility criteria will be enrolled into the study. The purpose of the Pfizer Registry of Outcomes in Growth hormone RESearch (PROGRES) study will be to assess the long-term safety and effectiveness of Genotropin, other daily hGH treatments, and Ngenla, a long-acting hGH, once granted marketing authorization and is commercially available under routine clinical care and is intended to reflect outcomes that occur in real-world clinical practice.
• Study status:
  Ongoing

Research institution and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned: 01/02/2021

Actual: 21/02/2021

Study start date

Planned: 18/10/2021

Actual: 19/11/2021

Data analysis start date

Planned: 18/10/2021

Date of interim report, if expected

Planned: 01/10/2022

Date of final study report

Planned: 26/05/2031

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer, Inc.

Regulatory

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