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Eur J Endocrinol. 2017 Aug;177(2):195-205. doi: 10.1530/EJE-16-0905. Epub 2017 May 31.

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

Author information

1
Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
2
Department of Endocrinology, The Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
3
Department of Pediatrics, The First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China.
4
Department of Endocrinology, Children's Hospital of Fudan University, Shanghai, China.
5
Department of Endocrinology, Beijing Children's Hospital, Capital Medical University, Beijing, China.
6
Department of Pediatrics, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China.
7
Department of Endocrinology, Shenzhen Children's Hospital, Shenzhen, China.
8
Department of Pediatrics, The First Hospital of Jilin University, Changchun, Jilin, China.

Abstract

OBJECTIVE:

We 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).

DESIGN:

Phase II and III, multicenter, open-label, randomized controlled trials.

METHODS:

108 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.

RESULTS:

The 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.

CONCLUSION:

Jintrolong 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.

PMID:
28566441
PMCID:
PMC5488390
DOI:
10.1530/EJE-16-0905
[Indexed for MEDLINE]
Free PMC Article

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