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A Study to Compare the Experiences of Taking Daily Growth Hormone Injections to Weekly Ngenla in Children With Low Levels of Growth Hormone

Pediatric Growth Hormone Deficiency Clinical Trial

Official title:
A MULTICENTER LOW-INTERVENTIONAL STUDY TO EVALUATE AND MONITOR TREATMENT EXPERIENCE WITH WEEKLY GROWTH HORMONE (NGENLA) VERSUS DAILY GROWTH HORMONE INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY

Clinical Trial Summary

The purpose of this study is to learn about: - how children stick to taking their injections - their experience with the study medicines (Ngenla and daily growth hormone) prescribed to children with low levels of growth hormone. This study is seeking participants who: - are being treated or are ready to start treatment with daily growth hormone or Ngenla. - use a sharps bin to collect used needles. The study medicines will be given as per regular care agreed with the doctor. The study will compare participant experiences to help us see: - the difference in how the participants stick to taking their daily growth hormone injections compared to participants using once weekly Ngenla. Participants will take part in this study for up to 14 months. During this time, they will have 3 study visits at the study clinic. The participants will use the HealthBeacon™ smart sharps bin for collecting the used needles or injections.

Clinical Trial Description

This multicenter, international, longitudinal, prospective, site-based, low-interventional study aims to evaluate and monitor treatment experience, defined by treatment adherence and persistence, in children aged 3-16 years old with a diagnosis of pediatric growth hormone deficiency (pGHD), receiving either daily growth hormone (dGH) treatment or once weekly Ngenla. The study is planned to be conducted in a total of 50 participating sites distributed across Belgium, Canada, France, Italy, Luxembourg, Spain, UK, and US. Data on treatment adherence and persistence will be collected in real-time over a period of 12 months using the HealthBeacon™ Smart Sharps Bin™ as a treatment monitoring device. Additional data, including demographic and clinical characteristics, will be collected at three timepoints, in line with the routine care in each participating site and/or country, over a maximum period of 14 months. Approximately 400 participants will be enrolled in the study (approximately 200 participants prescribed dGH injections and approximately 200 prescribed Ngenla). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06113952
Study type Observational
Source Pfizer
Contact
Status Withdrawn
Phase
Start date January 2024
Completion date October 17, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT01718041 - Versartis Trial in Children to Assess Long-Acting Growth Hormone Phase 1/Phase 2
Terminated NCT02068521 - Versartis Long-Term Safety Study of Somavaratan Phase 2/Phase 3
Not yet recruiting NCT05509894 - Korean Post-marketing Surveillance Ngenla® Pre-filled Pen Injection for the Treatment of Pediatric Patients With Growth Disturbance Due to Insufficient Secretion of Growth Hormone
Completed NCT04633057 - A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency Phase 3
Completed NCT01592500 - Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children Phase 2
Active, not recruiting NCT02968004 - Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children Phase 3
Terminated NCT02413138 - Versartis Trial in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) to Assess Long-Acting Growth Hormone (Somavaratan, VRS-317) Phase 2/Phase 3