Actively Recruiting
Evaluation of the Propensity of Patients Under rhGH to Envision a Modification of Their Treatment Regimen Toward LAGH
Led by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Updated on 2024-08-07
500
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
Sponsors
C
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead Sponsor
T
The Belux Society for Pediatric Endocrinology and Diabetology (BELSPEED)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Daily subcutaneous injections of rhGH can be burdensome for patients, leading to poor adherence and reduced growth outcomes. This has spurred the development of long-acting GH (LAGH) analogues that allow for weekly, biweekly, or monthly injections. Previous studies on LAGH analogues have demonstrated their non-inferiority compared to daily rhGH in terms of increasing growth velocity and improving body composition in children and adults with growth hormone deficiency (GHD), respectively, without significant and unexpected adverse events. Since 2020, three molecules have received approval from the Food and Drug Administration (FDA) for the treatment of pediatric GHD: lonapegsomatropin, somatrogon, and somapacitan. These LAGH analogues may offer better patient acceptance, improved tolerance, and greater therapeutic flexibility. However, these LAGH analogues could also be associated with potential clinical issues in terms of therapeutic monitoring, incidence and duration of side effects, and long-term safety due to a non-physiological GH profile. The introduction of these new LAGH products will require clinicians to identify optimal candidates for LAGH therapy and gain knowledge on monitoring and adjusting treatment.
CONDITIONS
Official Title
Evaluation of the Propensity of Patients Under rhGH to Envision a Modification of Their Treatment Regimen Toward LAGH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Belgian and Luxembourgish patients currently under rhGH treatment for approved indications including growth hormone deficiency, Turner Syndrome, chronic renal insufficiency, Prader-Willi syndrome, Small for gestational age, Noonan Syndrome, or SHOX gene deficiency
- Male or female patients
- Aged 0 to 18 years
- Provided free written or electronic consent and oral consent
You will not qualify if you...
- None
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cliniques Universitaires Saint-Luc
Brussels, Woluwe-saint-lambert, Belgium, 1200
Actively Recruiting
Research Team
P
Philippe Lysy, MD, PhD
CONTACT
L
Laure Boutsen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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