Safety and Efficacy of CinnaGen Human Recombinant Growth Hormone in Comparison with Novo Nordisk Growth Hormone in Children with Idiopathic Growth Hormone Deficiency: A Randomized Clinical Trial
The main objective is the comparison of safety and efficacy of Iranian recombinant growth hormone (CinnaGen) with Novo Nordisk brand. This unblinded study will be conducted in Ali Asghar Children Hospital, Tehran. A total of 30 children with growth hormone deficiency (before puberty) will take part in this clinical trial. Inclusion criteria: age between 4 and 16 years, pre-pubertal or early puberty stage; height standard deviation score<-2 in diagnosis time; growth hormone level post stimulating test by clonidine <10 ng/ml; rule out of the other causes of growth hormone deficiency; Documented Pituitary or hypothalamic hormone deficiency or low 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
Exclusion criteria: acute or systemic disorders such as seizure, infectious diseases, chronic pulmonary infection, AIDS, chronic liver disease; Turner syndrome, chronic kidney disease; Any active malignancy; Contraindications of the administration of growth hormone (sleep apnea syndrome); Short stature due other causes of GHD; History of diabetes in patient or his/her first-degree relatives; prednisolone usage except for replacement therapy. Children will be allocated in two groups by simple randomisation method and will receive growth hormone of CinnaGen or Novo Nordisk in a cross-over design with a starting dose of subcutaneous injection every night 0.03 mg/kg/day. On each monthly visit, complete physical examination will be done and the maturity of the child will be assessed by the classification of Tanner. Children will receive a total of 6 months of drug intervention, three months in the intervention group with CinnaGen growth hormone and three months in the comparison group with Novo Nordisk growth hormone and vice versa in the next three months. Growth velocity (GV) will be the primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409064920N5
Registration date:2015-07-10, 1394/04/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-07-10, 1394/04/19
Registrant information
Name
Ramin Heshmat
Name of organization / entity
Chronic Diseases Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0086
Email address
rheshmat@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
CinnaGen Pharmaceutical Company (Sponsor)
Expected recruitment start date
2016-03-01, 1394/12/11
Expected recruitment end date
2016-12-30, 1395/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and Efficacy of CinnaGen Human Recombinant Growth Hormone in Comparison with Novo Nordisk Growth Hormone in Children with Idiopathic Growth Hormone Deficiency: A Randomized Clinical Trial
Public title
Comparison of the effects and adverse events of CinnaGen recombinant human growth hormone & Novo Nordisk growth hormone in children with growth hormone deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 4 and 16 years, pre-pubertal or early puberty stage; height standard deviation score<-2 in diagnosis time; growth hormone level post stimulating test by clonidine <10 ng/ml; rule out of the other causes of growth hormone deficiency; Documented Pituitary or hypothalamic hormone deficiency or low 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
Exclusion criteria: acute or systemic disorders such as seizure, infectious diseases, chronic pulmonary infection, AIDS, chronic liver disease; Turner syndrome, chronic kidney disease; Any active malignancy; Contraindications of the administration of growth hormone (sleep apnea syndrome); Short stature due other causes of GHD; History of diabetes in patient or his/her first-degree relatives; prednisolone usage except for replacement therapy.
Age
From 4 years old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Research Deputy Building, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
14144
Approval date
2016-04-16, 1395/01/28
Ethics committee reference number
IR.IUMS.REC.1395.27183
Health conditions studied
1
Description of health condition studied
Idiopatic Growth Hormone Dificiency
ICD-10 code
E23.0
ICD-10 code description
Hypopituitarism
Primary outcomes
1
Description
Growth velocity
Timepoint
befor intervention and at 3rd and 6th months of intervention
Method of measurement
assessment of height changes in time unit
Secondary outcomes
1
Description
Height Standard Deviation Score (HSDS)
Timepoint
befor intevention and in 3rd and 6th month of intervention
Method of measurement
Growth Calculator 2.01
2
Description
Height Velocity Standard Deviation Score (HVSDS)
Timepoint
At the end of 3rd and 6th month of intervention
Method of measurement
Growth Calculator 2.01
3
Description
The incidence of Adverse Events
Timepoint
befor intevention and in 3rd and 6th month of intervention
Method of measurement
Case report forms
4
Description
Weight
Timepoint
befor intevention and in 3rd and 6th month of intervention
Method of measurement
Scale
5
Description
Stutre status
Timepoint
befor intevention and in 3rd and 6th month of intervention
Method of measurement
Studiometer
Intervention groups
1
Description
Intervention group: administration of 0.03 mg/kg/day of CinnaGen recombinant growth hormone, by subcutaneous injection for 3 months
Category
Treatment - Drugs
2
Description
Control group: administration of 0.03 mg/kg/day of Novo Nordisk recombinant growth hormone, by subcutaneous injection for 3 months