Pfizer PROGRES

  • Research type

    Research Study

  • Full title

    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

  • IRAS ID

    301829

  • Contact name

    Mehul Tulsidas Dattani

  • Contact email

    m.dattani@ucl.ac.uk

  • Sponsor organisation

    Pfizer Inc.

  • Clinicaltrials.gov Identifier

    N/A, N/A

  • Duration of Study in the UK

    10 years, 2 months, 1 days

  • Research summary

    The Progres study will collect information about participants who are receiving a growth hormone treatment as part of their regular care. The study involves recording information about the participant’s medical treatment and health at routine clinic visits, and completion of two questionnaires. No extra clinic visits are necessary.

    This non-interventional study is designated as a Post-Authorization Safety Study (PASS) and is sponsored by Pfizer and will be conducted in approximately 512 participating sites in over 20 countries around the world. In the UK, the study is planned to enrol 800 patients from around 40 sites. Male and female patients of any age meeting the eligibility criteria can be enrolled into the study. Recruitment will continue until October 2029 and the study will end in October 2030.

  • REC name

    South Central - Hampshire B Research Ethics Committee

  • REC reference

    21/SC/0354

  • Date of REC Opinion

    14 Dec 2021

  • REC opinion

    Further Information Favourable Opinion