Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies.

Luo X, Hou L, Liang L, Dong G, Shen S, Zhao Z, Gong CX, Li Y, Du ML, Su Z, Du H, Yan C

European journal of endocrinology31 May 2017Cited by 89 (Europe PMC)

PMID28566441PMCIDPMC5488390DOI10.1530/eje-16-0905PepBankPUB-28566441

Summary

ObjectiveWe assessed the efficacy and safety of a weekly pegylated human growth hormone (PEG-rhGH) (Jintrolong) vs daily rhGH for children with growth hormone deficiency (GHD).DesignPhase II and III, multicenter, open-label, randomized controlled trials.Methods108 and 343 children with treatment-naive GHD from 6 hospitals in China were enrolled in the phase II and III studies respectively. Patients in the phase II study were randomized 1:1:1 to weekly Jintrolong (0.1 mg/kg/week PEG-rhGH complex), weekly Jintrolong (0.2 mg/kg/week PEG-rhGH complex) or daily rhGH (0.25 mg/kg/week) for 25 weeks. Patients in the phase III study were randomized in a 2:1 ratio to weekly Jintrolong (0.2 mg/kg/week) or daily rhGH (0.25 mg/kg/week) for 25 weeks. The primary endpoint for both studies was height velocity (HV) increase at the end of treatment. Other growth-related parameters, safety and compliance were also monitored.ResultsThe phase II study established the preliminary efficacy, safety and recommended dose of Jintrolong PEG-rhGH. In the phase III study, we demonstrated significantly greater HV increases in patients receiving Jintrolong treatment (from 2.26 ± 0.87 cm/year to 13.41 ± 3.72 cm/year) vs daily rhGH (from 2.25 ± 0.82 cm/year to 12.55 ± 2.99 cm/year) at the end of treatment (P < 0.05). Additionally, significantly greater improvement in the height standard deviation scores was associated with Jintrolong throughout the treatment (P < 0.05). Adverse event rates and treatment compliance were comparable between the two groups.ConclusionJintrolong PEG-rhGH at a dose of 0.2 mg/kg/week for 25 weeks is effective and safe for GHD treatment and is non-inferior to daily rhGH.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In children with growth hormone deficiency, daily rhGH produced a smaller height velocity increase than Jintrolong, from 2.25 to 12.55 cm/year.
In plain wordsIn children with growth hormone deficiency, daily rhGH increased height velocity less than Jintrolong.
Peptide
HGH (somatotropin)
Outcome
DecreaseHeight velocity in phase III
Study
n = 343
Comparator
Weekly Jintrolong 0.2 mg/kg/week
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.25 mg/kg/week daily · 25 weeksAs given in this study (human).
Measurements
Baseline height velocity
2.25 cm/year
daily rhGH
Baseline height velocity SD
0.82 cm/year
daily rhGH
Final height velocity
12.55 cm/year
daily rhGH
Final height velocity SD
2.99 cm/year
daily rhGH
Source sentences
Summary
In the phase III study, we demonstrated significantly greater HV increases in patients receiving Jintrolong treatment (from 2.26 ± 0.87 cm/year to 13.41 ± 3.72 cm/year) vs daily rhGH (from 2.25 ± 0.82 cm/year to 12.55 ± 2.99 cm/year) at the end of treatment (P < 0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
Phase II and III, multicenter, open-label, randomized controlled trials.
Summary · context
Patients in the phase III study were randomized in a 2:1 ratio to weekly Jintrolong (0.2 mg/kg/week) or daily rhGH (0.25 mg/kg/week) for 25 weeks.
Show in the study text Report a problemFND-2856644101
02HumanRandomized controlled trialEfficacy outcome
In children with growth hormone deficiency, daily rhGH improved height standard deviation scores less than Jintrolong (P < 0.05).
In plain wordsIn children with growth hormone deficiency, daily rhGH improved height scores less than Jintrolong.
Peptide
HGH (somatotropin)
Outcome
DecreaseHeight standard deviation score improvement
Study
n = 343
Comparator
Weekly Jintrolong 0.2 mg/kg/week
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.25 mg/kg/week daily · 25 weeksAs given in this study (human).
Source sentences
Summary
Additionally, significantly greater improvement in the height standard deviation scores was associated with Jintrolong throughout the treatment (P < 0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
Phase II and III, multicenter, open-label, randomized controlled trials.
Summary · context
Patients in the phase III study were randomized in a 2:1 ratio to weekly Jintrolong (0.2 mg/kg/week) or daily rhGH (0.25 mg/kg/week) for 25 weeks.
Show in the study text Report a problemFND-2856644102
03HumanRandomized controlled trialSafety outcome
In children with growth hormone deficiency, adverse event rates were comparable with daily rhGH and Jintrolong.
In plain wordsIn children with growth hormone deficiency, adverse event rates were comparable with daily rhGH and Jintrolong.
Peptide
HGH (somatotropin)
Outcome
No significant changeAdverse event rates
Study
n = 343
Comparator
Weekly Jintrolong 0.2 mg/kg/week
Outcome group
Adverse events · Whole body
Studied dose
0.25 mg/kg/week daily · 25 weeksAs given in this study (human).
Source sentences
Summary
Adverse event rates and treatment compliance were comparable between the two groups.
2 context sentences(design, population, supporting numbers)
Summary · context
Phase II and III, multicenter, open-label, randomized controlled trials.
Summary · context
Patients in the phase III study were randomized in a 2:1 ratio to weekly Jintrolong (0.2 mg/kg/week) or daily rhGH (0.25 mg/kg/week) for 25 weeks.
Show in the study text Report a problemFND-2856644103
04HumanRandomized controlled trialOther
In children with growth hormone deficiency, treatment compliance was comparable with daily rhGH and Jintrolong.
In plain wordsIn children with growth hormone deficiency, treatment compliance was comparable with daily rhGH and Jintrolong.
Peptide
HGH (somatotropin)
Outcome
No significant changeTreatment compliance
Study
n = 343
Comparator
Weekly Jintrolong 0.2 mg/kg/week
Outcome group
Treatment adherence and retention · Whole body
Studied dose
0.25 mg/kg/week daily · 25 weeksAs given in this study (human).
Source sentences
Summary
Adverse event rates and treatment compliance were comparable between the two groups.
2 context sentences(design, population, supporting numbers)
Summary · context
Phase II and III, multicenter, open-label, randomized controlled trials.
Summary · context
Patients in the phase III study were randomized in a 2:1 ratio to weekly Jintrolong (0.2 mg/kg/week) or daily rhGH (0.25 mg/kg/week) for 25 weeks.
Show in the study text Report a problemFND-2856644104

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT01495468

Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children

Changchun GeneScience Pharmaceutical Co., Ltd.n = 343Mar 2007 to Mar 2008

Growth Hormone Deficiency

Trial page ClinicalTrials.govUpdated 31 Jul 2017

CompletedPhase 2NCT01342146

Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children

Changchun GeneScience Pharmaceutical Co., Ltd.n = 101May 2006 to Feb 2007

Growth Hormone Deficiency

Trial page ClinicalTrials.govUpdated 31 Jul 2017

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

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