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
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.
Summary of study results:
The PROGRES Study which stands for Pfizer Registry of Outcomes in Growth hormone RESearch, is a multicountry, non-interventional, prospective cohort study among patients with human growth hormone (hGH) treatments under routine clinical care.
The sponsor of this research is Pfizer, Inc. who also funded the conduct of this project.The population involvement was of 1516 participants of any age who met the criteria to take part in the study and they were enrolled by physicians who were routinely involved in the care of the patients and prescribed human growth hormone (hGH) as per standard of care.
The study took place from 19Nov2021 to 30Apr2024 in 18 countries: Australia, Belgium, Canada, Czech Republic, France, Germany, Ireland, Israel, Italy, Japan, Republic of Korea, Slovenia, Spain, Sweden, Taiwan, United Arab Emirates, United Kingdom, United States.
The purpose of this study was to learn more about the safety and effectiveness of human growth hormone treatments in routine practice.
The study participants' treatment during the study was of Human growth hormone treatments including Genotropin, Humatrope, Omnitrope, Norditropin, and Ngenla, as prescribed by their care team in routine clinical practice. The treatments they received were not influenced in any way by their participation in the study.
As per data collected, the most common adverse events that the subjects experienced were joint pain or stiffness, headaches, and pain or irritation at the injection site.
The study was intended to follow the 1516 enrolled subjects for several years, but the study was terminated early through Sponsor's decision. Participants characteristics at the time of enrollment were collected, but due to early study termination, long-term assessments of outcomes was not possible.
After study termination, data analysis was performed and it showed that among the 1516 subjects included in analyses, males were represented in the cohort more than females, participants were largely from Europe and North America and were aged 11.1 years, on average, at the time of enrollment. Subjects were diagnosed with Growth Hormone Deficiency (GHD) at a mean age of 7.7 years and the majority of them were reported as having idiopathic GHD (meaning that the cause of the growth hormone deficiency could not be determined). Few safety events were reported during the study, which is consistent with prior evidence of relatively low rates of safety events for the treatments included in this study.
Data collected contribute to the known safety profile of Genotropin, Other daily hGH treatment, and Ngenla, a weekly hGH treatment. Sparse follow-up data for all treatment groups limits the ability to draw conclusions on the effectiveness of these treatments on height gain and adult height.
As this study was discontinued prematurely, no further research is planned.
More details about the study can be accessed on:
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fcatalogues.ema.europa.eu%252Fnode%252F3091%252Fadministrative-details%2FNBTI%2F8eS6AQ%2FAQ%2F81722d20-fc30-43b1-a1fb-6b8ddb8abe0b%2F2%2FxeDjdu06t3&data=05%7C02%7Champshireb.rec%40hra.nhs.uk%7Ccefd8e31e4234f8f07f208dd3bbbe64d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638732400382045615%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=HdfpmfZ3B85R0N8qcquTBgQ7co0ovfSUU2FyP1H8rpg%3D&reserved=0REC 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