Evaluation of the safety and efficacy of biosimilar recombinant growth hormone in children with growth hormone deficiency: non-inferiority, randomized, parallel, multicentric and Phase III trial-Reference-Cited by-同舟云学术

Evaluation of the safety and efficacy of biosimilar recombinant growth hormone in children with growth hormone deficiency: non-inferiority, randomized, parallel, multicentric and Phase III trial

Published:2024-05-08 Issue: Volume: Page:1-9
ISSN:1474-0338
Container-title:Expert Opinion on Drug Safety
language:en
Short-container-title:Expert Opinion on Drug Safety

Author:

Zaeri Hossein¹,Omidvar Shahriar²,Servatian Nazli²³,Arefnia Serajaddin¹,Khademolreza Nasrin²,Amini Hossein²⁴,Taghavi Behnam²,Hashemipour Mahin⁵,Eshraghi Peyman⁶,Ghasemi Mahmoud⁷,Ghergherehchi Robabeh⁸,Maleki Elham⁹,Moravej Hossein¹⁰,Noorian Shahab¹¹,Soheilipour Fahimeh¹²,Dalili Setila¹³,Kharazmi Hosseinali¹⁴,Didban Abdollah¹⁵,Akhlaghi Aliasghar¹⁶,Ghaznavi Sina²,Shahbazi Majid²⁴

Affiliation:

1. Neonatal and Children's Health Research Center, Golestan University of Medical Sciences, Gorgan, Iran

2. Department of Pediatric Endocrinology, AryaTinaGene Biopharmaceutical Company, Gorgan, Iran

3. Department of Hematology and Cell Therapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran

4. Medical Cellular and Molecular Research Center, Golestan University of Medical Sciences, Gorgan, Iran

5. Metabolic Liver Disease Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

6. Pediatric Endocrinology Department, Akbar Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

7. Department of Pediatrics, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran

8. Department of Pediatric, Tabriz University of Medical Sciences, Tabriz, Iran

9. Endocrinology and Metabolism Research Center, Institute of Basic and Clinical Physiology Science, Kerman University of Medical Sciences, Kerman, Iran

10. Department of Pediatric Endocrinology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

11. Department of Pediatric Endocrinology and Metabolism, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran

12. Pediatric Growth and Development Research Center, Institute of Endocrinology and Metabolism, Ali Asghar Children Hospital, School of Medicine, Iran University of Medical Sciences, Tehran, Iran

13. Pediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran

14. Endocrinology and Metabolism Research Center, School of Medicine, Hormozgan University of Medical Sciences, Bandar Abas, Iran

15. Children Growth Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran

16. Department of Epidemiology and Reproductive Health, Reproductive Epidemiology Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Funder

Arya Tina Gene biopharmaceutical company

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/14740338.2024.2348576

Reference27 articles.

1. Zapf J, Froesch E. Insulin-like growth factor I actions on somatic growth. In: Kostyo J, editor. Handbook of physiology. Philadelphia: American Physiological Society; 1999. p. 663–99.

2. Sperling MA. Sperling pediatric endocrinology. 5th ed. Philadelphia: Elsevier; 2020. Available from: https://www.asia.elsevierhealth.com/sperling-pediatric-endocrinology-9780323625203.html

3. Long-Term Outcomes, Genetics, and Pituitary Morphology in Patients with Isolated Growth Hormone Deficiency and Multiple Pituitary Hormone Deficiencies: A Single-Centre Experience of Four Decades of Growth Hormone Replacement

4. Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort

5. Growth hormone therapy in children; research and practice – A review