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

• Status: Completed
• Trial end date: 2017-02-04
• Target enrollment: 0
• Participant gender: All

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®.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cinnagen
• Treatments: Hormones

Criteria

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• • 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