IRCT20150303021315N12 IRCT 2019-04-07 CinnaGen company Comparing CinnaTropin® with Norditropin® NordiLet® in pre-pubertal children with growth hormone deficiency A randomized, two-armed, parallel, active-controlled clinical trial to compare equivalent efficacy along with safety, and immunogenicity of CinnaTropin® (CinnaGen, Iran) to Norditropin® NordiLet® (Novo Nordisk, Denmark) in pre-pubertal children with growth hormone deficiency (GHD) 2018-12-14 anticipated 102 Complete https://irct.ir/trial/34400 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization plan of the patients will be carried out centrally using an R-CRAN software version 3.2.3. Blocks (with the size 2 or 4) will be made using permuted block randomization for a total of 102 patients (1:1 allocation ratio). After the randomization procedure, a code will be allocated to each patient that will be used as a patient-identifier throughout the study. The assigned code will be denoted by 4 initials (corresponding to the first two letters of the first name, first two letters of surname) and 3 numbers (center code). Moreover, the code described is followed by the study unique identification code consisting of first three letters of the name of the investigational product (which is CIN-) and three numbers (corresponding to the randomization number), e.g. ABCD001CIN-001. The randomization number will be assigned in a consecutive way. 3 Isolated idiopathic growth hormone deficiency. Intervention 1: Control group: CinnaTropin® pen-injector (5 mg/1.5 mL, CinnaGen, Iran), SC injection of 0.03 mg/kg for one year. Intervention 2: Control group: Norditropin® NordiLet® pen (5 mg/1.5 mL, Novo Nordisk, Denmark), SC injection of 0.03 mg/kg for one year. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Sharing policy is still unknown