Comparing Efficacy and Safety of CinnaGen Biosimilar Growth Hormone (CinnaTropin®) Versus Nordilet in Children With Idiopathic Growth Hormone Deficiency

NCT03223025 | Completed Phase 3

• 2 other identifiers: GH.CIN.MR93IRCT201409064920N5
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized, active-controlled, two-armed, open-label, and cross-over trial was designed to compare efficacy and safety of 0.03 mg/kg/day subcutaneous injections of either CinnaTropin® or Novo Nordisk growth hormone product in 30 children with Idiopathic Growth Hormone Deficiency. Patients were randomized to receive one of the products for three months. After that, each patient crossed over to the other arm to receive the other product for another three months. The primary objective of this study was to compare the efficacy of CinnaGen growth hormone (GH) with Nordilet. The secondary objectives of this study were further comparison and evaluation of efficacy along with safety between CinnaTropin® and Nordilet®.

Conditions

Idiopathic Growth Hormone Deficiency

Keywords

IGHD; somatropin

Outcome Measures

Primary Outcomes (1)

• Height velocity

  The primary outcome of this study is to compare height velocity of patients in each treatment arm. Height velocity is reported in terms of centimeters per year.

  three months

Secondary Outcomes (6)

• Height

  three months

• Weight

  three months

• Bone Age

  six months

• HSDS

  three months

• HVSDS

  three months

Study Arms (2)

CinnaTropin®, Then Nordilet®

EXPERIMENTAL

CinnaTropin® was administered with 0.03 mg/kg daily subcutaneous injections for three months. After that, the participants received 0.03 mg/kg daily subcutaneous injections of Nordilet® for three months.

Drug: CinnaTropin®; Drug: Nordilet®

Nordilet®, Then CinnaTropin®

ACTIVE COMPARATOR

Nordilet® was administered with 0.03 mg/kg daily subcutaneous injections for three months. After that, the participants received 0.03 mg/kg daily subcutaneous injections of CinnaTropin® for three months.

Drug: CinnaTropin®; Drug: Nordilet®

Interventions

CinnaTropin® DRUG

0.03 mg/kg daily subcutaneous injections

Also known as: recombinant human growth hormone (CinnaTropin®)

CinnaTropin®, Then Nordilet®; Nordilet®, Then CinnaTropin®

Nordilet® DRUG

0.03 mg/kg daily subcutaneous injections

Also known as: recombinant human growth hormone (Nordilet®)

CinnaTropin®, Then Nordilet®; Nordilet®, Then CinnaTropin®

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pre-pubertal boys and girls between 4-16 years (Tanner's stage 1)
• Height Standard Deviation Score (HSDS) ≤ -2 SD for chronological age (Brandt/Reinken)
• Approved GH Deficiency following clonidine GH stimulation test (150 µg/ m2, up to a maximum of 0.2 mg), and determining GH levels at 0, 30, 60, 90, and 120 minutes. This test is performed by overnight fasting and considered positive if GH ≥ 10 ng/ml, otherwise GHD is relevant.
• Ruling out of other causes of short stature (hypothyroidism, Celiac disease, and etc.)
• Documented Pituitary or hypothalamic hormone deficiency and below normal serum IGF-1 at the time of diagnosis
• In case of the deficiency in other pituitary hormones, the patient can only be included, if the replacement of other pituitary hormones was done, and this is determined by the replacement of glucocorticoids provided that no symptoms of Cushing's syndrome be present, and the replacement of thyroxine and reaching to normal levels of free T4 and free T3.

You may not qualify if:

• Any Illness that prevent the proper conduct of the trial, such as seizure, acute or systemic infectious disease in the past 6 months, chronic pulmonary infection, AIDS, chronic liver disease (verified disease of the hepatic cells or 2-fold or more increase in liver enzymes)
• Any active malignancy (such as leukemia, etc.),
• Contraindications of the administration of growth hormone (sleep apnea syndrome)
• Turner syndrome.
• Short stature due to chronic renal failure, other causes of GHD, such as craniopharyngioma
• History of diabetes in patient or his/her first-degree relatives
• Concomitant use of steroids

Sponsors & Collaborators

• Cinnagen: lead

Related Publications (14)

• Kato Y, Murakami Y, Sohmiya M, Nishiki M. Regulation of human growth hormone secretion and its disorders. Intern Med. 2002 Jan;41(1):7-13. doi: 10.2169/internalmedicine.41.7.

  PMID: 11838603 BACKGROUND

• Henwood MJ, Grimberg A, Moshang T Jr. Expanded spectrum of recombinant human growth hormone therapy. Curr Opin Pediatr. 2002 Aug;14(4):437-42. doi: 10.1097/00008480-200208000-00015.

  PMID: 12130909 BACKGROUND

• Frindik JP, Kemp SF, Sy JP. Effects of recombinant human growth hormone on height and skeletal maturation in growth hormone-deficient children with and without severe pretreatment bone age delay. Horm Res. 1999;51(1):15-9. doi: 10.1159/000023307.

  PMID: 10095164 BACKGROUND

• Lanes R. Growth velocity, final height and bone mineral metabolism of short children treated long term with growth hormone. Curr Pharm Biotechnol. 2000 Jul;1(1):33-46. doi: 10.2174/1389201003378997.

  PMID: 11467359 BACKGROUND

• Shulman DI, Root AW, Diamond FB, Bercu BB, Martinez R, Boucek RJ Jr. Effects of one year of recombinant human growth hormone (GH) therapy on cardiac mass and function in children with classical GH deficiency. J Clin Endocrinol Metab. 2003 Sep;88(9):4095-9. doi: 10.1210/jc.2003-030030.

  PMID: 12970269 BACKGROUND

• Bernasconi S, Arrigo T, Wasniewsk M, Ghizzoni L, Ruggeri C, Di Pasquale G, Vottero A, De Luca F. Long-term results with growth hormone therapy in idiopathic hypopituitarism. Horm Res. 2000;53 Suppl 1:55-9. doi: 10.1159/000053206.

  PMID: 10895044 BACKGROUND

• Gasperi M, Aimaretti G, Scarcello G, Corneli G, Cosci C, Arvat E, Martino E, Ghigo E. Low dose hexarelin and growth hormone (GH)-releasing hormone as a diagnostic tool for the diagnosis of GH deficiency in adults: comparison with insulin-induced hypoglycemia test. J Clin Endocrinol Metab. 1999 Aug;84(8):2633-7. doi: 10.1210/jcem.84.8.5904.

  PMID: 10443652 BACKGROUND

• Biller BM, Vance ML, Kleinberg DL, Cook DM, Gordon T. Clinical and reimbursement issues in growth hormone use in adults. Am J Manag Care. 2000 Sep;6(15 Suppl):S817-27.

  PMID: 11184423 BACKGROUND

• Bright GM, Julius JR, Lima J, Blethen SL. Growth hormone stimulation test results as predictors of recombinant human growth hormone treatment outcomes: preliminary analysis of the national cooperative growth study database. Pediatrics. 1999 Oct;104(4 Pt 2):1028-31.

  PMID: 10506258 BACKGROUND

• Janssen YJ, Frolich M, Roelfsema F. The absorption profile and availability of a physiological subcutaneously administered dose of recombinant human growth hormone (GH) in adults with GH deficiency. Br J Clin Pharmacol. 1999 Mar;47(3):273-8. doi: 10.1046/j.1365-2125.1999.00892.x.

  PMID: 10215751 BACKGROUND

• Drake WM, Howell SJ, Monson JP, Shalet SM. Optimizing gh therapy in adults and children. Endocr Rev. 2001 Aug;22(4):425-50. doi: 10.1210/edrv.22.4.0438.

  PMID: 11493578 BACKGROUND

• De Muinck Keizer-Schrama S, Rikken B, Hokken-Koelega A, Wit JM, Drop S. Comparative effect of two doses of growth hormone for growth hormone deficiency. The Dutch Growth Hormone Working Group. Arch Dis Child. 1994 Jul;71(1):12-8. doi: 10.1136/adc.71.1.12.

  PMID: 8067786 BACKGROUND

• Soliman AT, abdul Khadir MM. Growth parameters and predictors of growth in short children with and without growth hormone (GH) deficiency treated with human GH: a randomized controlled study. J Trop Pediatr. 1996 Oct;42(5):281-6. doi: 10.1093/tropej/42.5.281.

  PMID: 8936959 BACKGROUND

• Rikken B, van Doorn J, Ringeling A, Van den Brande JL, Massa G, Wit JM. Plasma levels of insulin-like growth factor (IGF)-I, IGF-II and IGF-binding protein-3 in the evaluation of childhood growth hormone deficiency. Horm Res. 1998 Sep;50(3):166-76. doi: 10.1159/000023268.

  PMID: 9762006 BACKGROUND

MeSH Terms

Interventions

Growth Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 19, 2017
• Study Start: March 9, 2016
• Primary Completion: February 4, 2017
• Study Completion: February 4, 2017
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share