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作者

Xiao Yu, Xinran Cheng, Haiyan Wei, Xu Xu, Chunxiu Gong, Guimei Li, Hui Yao, Li Zhou, Yan Zhong, Yu Yang, Feihong Luo, Yining Zhang, Frank Huang, Xiaofeng Shi, Patrick Cabri, Xiaoping Luo

作者单位

Affiliations ¹ Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, Hubei,, China. ² Department of Endocrinology and Metabolism, Chengdu Women's and Children's Central Hospital, Chengdu, China. ³ Department of Endocrinology and Genetic, Children's Hospital Affiliated to Zhengzhou University, Zhengzhou, China. ⁴ Department of Pediatric Endocrinology, Wuxi Children's Hospital, Wuxi, China. ⁵ Department of Endocrinology, Genetics and Metabolism, National Center for Children's Health, Beijing Children's Hospital, Capital Medical University, Beijing, China. ⁶ Department of Pediatric Endocrinology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China. ⁷ Department of Pediatrics, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China. ⁸ Department of Children's Health, Pingxiang Maternity and Child Care, Pingxiang, China. ⁹ Department of Child Healthcare, Hunan Children's Hospital, Changsha, China. ¹⁰ Department of Endocrinology, Metabolism, and Genetics, Children's Hospital of Nanchang University & Jiangxi Provincial Children's Hospital, Nanchang, China. ¹¹ Department of Endocrinology, Metabolism and Genetics, Children's Hospital of Fudan University, Shanghai, China. ¹² Department of Endocrinology, Genetics and Metabolism, The First Hospital of Jilin University, Changchun, China. ¹³ Ipsen (Shanghai) Innovation Pharmaceutical Co., Ltd, Shanghai, China. ¹⁴ Ipsen, Boulogne-Billancourt, France. ¹⁵ Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, Hubei,, China. xpluo@tjh.tjmu.edu.cn.

刊名

Advances in therapy

年份

2024

卷号

Vol.41 No.12

页码

4537-4556

ISSN

1865-8652

关键词

Central precocious puberty Chinese children Triptorelin.

摘要

Introduction: This phase 3 study assessed the efficacy, safety, and pharmacokinetics of the 6-month prolonged release formulation in Chinese children with central precocious puberty . Methods: In this open-label study , Chinese children received two doses of triptorelin pamoate 22.5 mg . Primary endpoint was the proportion at month 6 with luteinizing hormone suppression . Secondary endpoints included safety assessments, hormone level changes, and clinical parameters from baseline. Results: Ov...更多

Introduction: This phase 3 study assessed the efficacy, safety, and pharmacokinetics of the 6-month prolonged release formulation in Chinese children with central precocious puberty . Methods: In this open-label study , Chinese children received two doses of triptorelin pamoate 22.5 mg . Primary endpoint was the proportion at month 6 with luteinizing hormone suppression . Secondary endpoints included safety assessments, hormone level changes, and clinical parameters from baseline. Results: Overall, 66 children completed the study . At month 6, all patients had LH suppression; this was maintained at month 12 in 98.5% of patients. Mean basal and peak LH and follicle-stimulating hormone levels were suppressed throughout follow-up. All patients at months 3 to 12 had sex hormone suppression to prepubertal levels. Stable or reduced breast development was seen for 98.4% and 93.5% of girls at month 6 and 12, respectively; all boys had regression or stable genital development until month 12. Compared with baseline , mean growth velocity was 5.88 cm/year at month 6 and 5.17 cm/year at month 12. Mean bone age/chronological age ratio decreased from 1.27 at baseline to 1.23 and 1.21 at month 6 and 12, respectively. In girls, 64.5% showed decreased uterine length at month 6 and 12 versus baseline, while 75.0% of boys showed stable testicular volume versus baseline. Thirteen patients had 22 drug-related treatment emergent adverse events ; no grade ≥ 3 TEAEs were reported. Conclusion: The efficacy and safety profile of triptorelin 6-month PR in Chinese children with CPP was consistent with data previously reported in non-Chinese children with CPP, supporting this as a viable treatment option for Chinese children with CPP. Trial registration: Trial registration: ClinicalTrials.gov identifier, NCT05029622.收起

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