Trial reportHormone research in paediatrics2018
Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized, Controlled Phase II Study.
Trial report in Hormone research in paediatrics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 20 citations in OpenAlex.
- Weekly long-acting growth hormone versus daily growth hormone therapy on quality of life, efficacy, and safety in children with short stature: a systematic review and meta-analysis.Frontiers in endocrinology · 2026Pooled it
- Effect of Weekly Long-Acting Growth Hormone Replacement Therapy Compared to Daily Growth Hormone on Children With Short Stature: A Meta-Analysis.Frontiers in endocrinology · 2021Pooled it
- Efficacy and safety of long-acting growth hormone in children with short stature: a systematic review and meta-analysis.Endocrine · 2019Pooled it
- Treatment with long-acting growth hormone: effectiveness and safety.Frontiers in endocrinology · 2026Review
- Effect of long-acting PEGylated growth hormone for catch-up growth in children with idiopathic short stature: a 2-year real-world retrospective cohort study.European journal of pediatrics · 2024Article
- Growth hormone receptor agonists and antagonists: From protein expression and purification to long-acting formulations.Protein science : a publication of the Protein Society · 2023Review
- Long-acting growth hormone in 2022.Pediatric investigation · 2023Review
- Long acting growth hormone (LAGH), an update.Frontiers in pediatrics · 2023Review
- New insight into the importance of formulation variables on parenteral growth hormone preparations: potential effect on the injection-site pain.Frontiers in endocrinology · 2022Review
- What do we do now that the long-acting growth hormone is here?Frontiers in endocrinology · 2022Review
- Height outcomes in Korean children with idiopathic short stature receiving growth hormone treatment.Frontiers in endocrinology · 2022Article
- Usefulness and Potential Pitfalls of Long-Acting Growth Hormone Analogs.Frontiers in endocrinology · 2021Review
- Long-Acting Growth Hormone Preparations - Current Status and Future Considerations.The Journal of clinical endocrinology and metabolism · 2020Review
- Perspectives on long-acting growth hormone therapy in children and adults.Archives of endocrinology and metabolismReview
Corrections and comments
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Authors and funding
13 authors at 12 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
aimsTo determine the optimal dose of LB03002, a sustained-release, once-weekly formulation of recombinant human growth hormone (rhGH), and to compare its efficacy and safety with daily rhGH in children with idiopathic short stature (ISS).
methodsThis multicenter, randomized, open-label, phase II study included GH-naïve, prepubertal children with ISS, randomized to receive daily rhGH 0.37 mg/kg/week (control, n = 16), LB03002 0.5 mg/kg/week (n = 14), or LB03002 0.7 mg/kg/week (n = 16). The primary endpoint was height velocity (HV) change at week 26.
resultsAt week 26, the least square (LS) means for HV change (cm/year) with control, LB03002 0.5 mg/kg/week, and LB03002 0.7 mg/kg/week were 5.08, 3.65, and 4.38, and the LS means for the change in height standard deviation score were 0.65, 0.49, and 0.58, respectively. The lower bound of the 90% confidence interval for the difference between LB03002 0.7 mg/kg/week and the control in the LS mean for HV change (-1.72) satisfied the noninferiority margin (-1.75). Adverse events were generally mild and short-lived.
conclusionA once-weekly regimen of LB03002 0.7 mg/kg demonstrated noninferiority to the daily regimen of rhGH 0.37 mg/kg/week in terms of HV increments. LB03002 was well tolerated and its safety profile was comparable with that of daily rhGH.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.