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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

Tracking Information
First Submitted Date  ICMJE July 18, 2017
First Posted Date  ICMJE July 19, 2017
Last Update Posted Date July 21, 2017
Actual Study Start Date  ICMJE March 9, 2016
Actual Primary Completion Date February 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
  • Height [ Time Frame: three months ]
    Changes in height is measured in both treatment arms.
  • Weight [ Time Frame: three months ]
    Changes in height is measured in both treatment arms.
  • Bone Age [ Time Frame: six months ]
    Bone age is determined by wrist x-ray radiography in both treatment arms
  • HSDS [ Time Frame: three months ]
    Height standard deviation score is calculated to compare height based on reference population.
  • HVSDS [ Time Frame: three months ]
    Height velocity standard deviation score (HVSDS) is calculated to assess height velocity based on reference population.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Efficacy and Safety of CinnaGen Biosimilar Growth Hormone (CinnaTropin®) Versus Nordilet in Children With Idiopathic Growth Hormone Deficiency
Official Title  ICMJE 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)
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®.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Growth Hormone Deficiency
Intervention  ICMJE
  • 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®)
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: CinnaTropin®
    • Drug: 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.
    Interventions:
    • Drug: CinnaTropin®
    • Drug: Nordilet®
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2017)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 4, 2017
Actual Primary Completion Date February 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03223025
Other Study ID Numbers  ICMJE GH.CIN.MR93
IRCT201409064920N5 ( Registry Identifier: Food And Drug Administration of The Islamic Republic of Iran )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cinnagen
Study Sponsor  ICMJE Cinnagen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cinnagen
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP