Comparing Efficacy and Safety of CinnaGen Biosimilar Growth Hormone (CinnaTropin®) Versus Nordilet in Children With Idiopathic Growth Hormone Deficiency
Condition: Idiopathic Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

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®.
    

Detailed description: 
      This study was a national, single center, randomized, active-controlled, two-arm, cross-over
      clinical trial to compare efficacy and safety of CinnaTropin® with Novo Nordisk growth
      hormone product in children with Idiopathic Growth Hormone Deficiency (IGHD).

      After signing the written informed consent, patients were randomized to receive daily
      subcutaneous injections of CinnaTropin® or reference product (0.03mg/kg/day). Patients were
      admitted to receive the medication based on planned treatment. After three months patients
      were switched to receive the other product for another three months. Treatment visits were
      monthly for both groups.

      The primary objective of this study is to compare the efficacy of CinnaTropin® with Novo
      Nordisk growth hormone product. The secondary objectives of this study are to further
      evaluation efficacy and safety.

      During the trial, if patients bone age reached 14 and the improvement in their height was
      less than 2.5 cm than last year or, they did not reach the desired height appropriate for
      their age and gender or, if the growth plates were closed and they couldn't reach appropriate
      adulthood height, treatment will be discontinued.

      The clinical trial was according to procedures that incorporate the ethical principles of
      GCP. Accurate and reliable data collection was assured by verification and cross-check of the
      CRFs against the patient's records by clinical monitors (source document verification was
      performed), and the maintenance of a drug-dispensing log by the center. A comprehensive
      validation check program was used to verify the data, and discrepancy reports were generated
      accordingly for resolution by the investigator.

      Determination of sample size was based on the mean growth velocity of 9.7±1.3 following
      treatment with growth hormone and under consideration of 80% power, a sample size of 6
      patient in each group was calculated. By considering patient loss and in order to increase
      the statistical power of the study a sample size of 15 patients in each group was determined.
    

Intervention name(s): CinnaTropin®; Nordilet®
Intervention type(s): Drug; Drug
Intervention description(s): 0.03 mg/kg daily subcutaneous injections; 0.03 mg/kg daily subcutaneous injections
Other intervention name(s): recombinant human growth hormone (CinnaTropin®); recombinant human growth hormone (Nordilet®)
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IGHD; somatropin