Idiopathic Growth Hormone Deficiency Clinical Trial
Official title:
Efficacy and Safety of CinnaGen Recombinant Human Growth Hormone (CinnaTropin®) in Comparison With Novo Nordisk Growth Hormone (Nordilet®) Product in Pre-Pubertal Children With Idiopathic Growth Hormone Deficiency (IGHD)
Verified date | August 2023 |
Source | Cinnagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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®.
Status | Completed |
Enrollment | 30 |
Est. completion date | February 4, 2017 |
Est. primary completion date | February 4, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 16 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cinnagen |
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Height | Changes in height is measured in both treatment arms. | three months | |
Secondary | Weight | Changes in height is measured in both treatment arms. | three months | |
Secondary | Bone Age | Bone age is determined by wrist x-ray radiography in both treatment arms | six months | |
Secondary | HSDS | Height standard deviation score is calculated to compare height based on reference population. | three months | |
Secondary | HVSDS | Height velocity standard deviation score (HVSDS) is calculated to assess height velocity based on reference population. | three months | |
Secondary | The incidence of Adverse Events | The incidence of adverse events at each visit is recorded based on patients' reports, vital signs, physical examinations, and laboratory tests for systemic safety, including liver function, renal function, complete blood count and clinical chemistries, urinalysis, and hematologic testing. | three months; From receiving the first dose of each recombinant human growth hormone product until the last dose; |
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