Actively Recruiting

Phase Not Applicable
Age: 1Day - 18Years
All Genders
NCT06542809

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

Age: 1Day - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • None

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Cliniques Universitaires Saint-Luc

Brussels, Woluwe-saint-lambert, Belgium, 1200

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Evaluation of the Propensity of Patients Under rhGH to Envision a Modification of Their Treatment Regimen Toward LAGH | DecenTrialz