Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03223025
Recruitment Status : Completed
First Posted : July 19, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Cinnagen

Brief 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®.

Condition or disease Intervention/treatment Phase
Idiopathic Growth Hormone Deficiency Drug: CinnaTropin® Drug: Nordilet® Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 9, 2016
Actual Primary Completion Date : February 4, 2017
Actual Study Completion Date : February 4, 2017


Arm Intervention/treatment
Experimental: CinnaTropin®, Then Nordilet®
CinnaTropin® was administered with 0.03 mg/kg daily subcutaneous injections for three months. After that, the participants received 0.03 mg/kg daily subcutaneous injections of Nordilet® for three months.
Drug: CinnaTropin®
0.03 mg/kg daily subcutaneous injections
Other Name: recombinant human growth hormone (CinnaTropin®)

Drug: Nordilet®
0.03 mg/kg daily subcutaneous injections
Other Name: recombinant human growth hormone (Nordilet®)

Active Comparator: Nordilet®, Then CinnaTropin®
Nordilet® was administered with 0.03 mg/kg daily subcutaneous injections for three months. After that, the participants received 0.03 mg/kg daily subcutaneous injections of CinnaTropin® for three months.
Drug: CinnaTropin®
0.03 mg/kg daily subcutaneous injections
Other Name: recombinant human growth hormone (CinnaTropin®)

Drug: Nordilet®
0.03 mg/kg daily subcutaneous injections
Other Name: recombinant human growth hormone (Nordilet®)




Primary Outcome Measures :
  1. Height velocity [ Time Frame: three months ]
    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.


Secondary Outcome Measures :
  1. Height [ Time Frame: three months ]
    Changes in height is measured in both treatment arms.

  2. Weight [ Time Frame: three months ]
    Changes in height is measured in both treatment arms.

  3. Bone Age [ Time Frame: six months ]
    Bone age is determined by wrist x-ray radiography in both treatment arms

  4. HSDS [ Time Frame: three months ]
    Height standard deviation score is calculated to compare height based on reference population.

  5. HVSDS [ Time Frame: three months ]
    Height velocity standard deviation score (HVSDS) is calculated to assess height velocity based on reference population.

  6. The incidence of Adverse Events [ Time Frame: three months; From receiving the first dose of each recombinant human growth hormone product until the last dose; ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications:

Layout table for additonal information
Responsible Party: Cinnagen
ClinicalTrials.gov Identifier: NCT03223025     History of Changes
Other Study ID Numbers: GH.CIN.MR93
IRCT201409064920N5 ( Registry Identifier: Food And Drug Administration of The Islamic Republic of Iran )
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cinnagen:
IGHD
somatropin
Additional relevant MeSH terms:
Layout table for MeSH terms
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs