AzTrials
AzTrials

Idiopathic Growth Hormone DeficiencyPhase 3NCT03223025

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

A Phase 3 study testing CinnaTropin® and Nordilet® in people with Idiopathic Growth Hormone Deficiency, run by Cinnagen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 4 to 16 years
Conditions the study is for
Idiopathic Growth Hormone Deficiency
What is being tested?
CinnaTropin® and Nordilet®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
9 Mar 2016to 4 Feb 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • • 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.

Who cannot join

  • • 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

About this study

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)

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®.

Read the 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.

Being tested
CinnaTropin®, Nordilet®
Keywords
IGHD, somatropin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CinnaTropin®Drug

    Also called recombinant human growth hormone (CinnaTropin®)

    0.03 mg/kg daily subcutaneous injections

  • Nordilet®Drug

    Also called recombinant human growth hormone (Nordilet®)

    0.03 mg/kg daily subcutaneous injections

Study groups in NCT03223025
Study groupRoleWhat they receive
CinnaTropin®, Then Nordilet®ExperimentalCinnaTropin® 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.
Receives: Drug: CinnaTropin®; Drug: Nordilet®
Nordilet®, Then CinnaTropin®Active comparatorNordilet® 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.
Receives: Drug: CinnaTropin®; Drug: Nordilet®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: three months

Secondary outcomes (6)

  1. Height

    Changes in height is measured in both treatment arms.

    Measured: three months

  2. Weight

    Changes in height is measured in both treatment arms.

    Measured: three months

  3. Bone Age

    Bone age is determined by wrist x-ray radiography in both treatment arms

    Measured: six months

  4. HSDS

    Height standard deviation score is calculated to compare height based on reference population.

    Measured: three months

  5. HVSDS

    Height velocity standard deviation score (HVSDS) is calculated to assess height velocity based on reference population.

    Measured: three months

  6. 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.

    Measured: three months; From receiving the first dose of each recombinant human growth hormone product until the last dose;

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2017
  2. Study start9 Mar 2016
  3. Primary completion4 Feb 2017
  4. Study completion4 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03223025
Sponsor's protocol ID
GH.CIN.MR93
Other IDs
IRCT201409064920N5
Status last verified
Aug 2023
First submitted
18 Jul 2017
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kato Y, Murakami Y, Sohmiya M, Nishiki M. Regulation of human growth hormone secretion and its disorders. Intern Med. 2002 Jan;41(1):7-13. doi: 10.2169/internalmedicine.41.7.

    PubMed 11838603

  • Henwood MJ, Grimberg A, Moshang T Jr. Expanded spectrum of recombinant human growth hormone therapy. Curr Opin Pediatr. 2002 Aug;14(4):437-42. doi: 10.1097/00008480-200208000-00015.

    PubMed 12130909

  • Frindik JP, Kemp SF, Sy JP. Effects of recombinant human growth hormone on height and skeletal maturation in growth hormone-deficient children with and without severe pretreatment bone age delay. Horm Res. 1999;51(1):15-9. doi: 10.1159/000023307.

    PubMed 10095164

  • Lanes R. Growth velocity, final height and bone mineral metabolism of short children treated long term with growth hormone. Curr Pharm Biotechnol. 2000 Jul;1(1):33-46. doi: 10.2174/1389201003378997.

    PubMed 11467359

  • Shulman DI, Root AW, Diamond FB, Bercu BB, Martinez R, Boucek RJ Jr. Effects of one year of recombinant human growth hormone (GH) therapy on cardiac mass and function in children with classical GH deficiency. J Clin Endocrinol Metab. 2003 Sep;88(9):4095-9. doi: 10.1210/jc.2003-030030.

    PubMed 12970269

  • Bernasconi S, Arrigo T, Wasniewsk M, Ghizzoni L, Ruggeri C, Di Pasquale G, Vottero A, De Luca F. Long-term results with growth hormone therapy in idiopathic hypopituitarism. Horm Res. 2000;53 Suppl 1:55-9. doi: 10.1159/000053206.

    PubMed 10895044

  • Gasperi M, Aimaretti G, Scarcello G, Corneli G, Cosci C, Arvat E, Martino E, Ghigo E. Low dose hexarelin and growth hormone (GH)-releasing hormone as a diagnostic tool for the diagnosis of GH deficiency in adults: comparison with insulin-induced hypoglycemia test. J Clin Endocrinol Metab. 1999 Aug;84(8):2633-7. doi: 10.1210/jcem.84.8.5904.

    PubMed 10443652

  • Biller BM, Vance ML, Kleinberg DL, Cook DM, Gordon T. Clinical and reimbursement issues in growth hormone use in adults. Am J Manag Care. 2000 Sep;6(15 Suppl):S817-27.

    PubMed 11184423

  • Bright GM, Julius JR, Lima J, Blethen SL. Growth hormone stimulation test results as predictors of recombinant human growth hormone treatment outcomes: preliminary analysis of the national cooperative growth study database. Pediatrics. 1999 Oct;104(4 Pt 2):1028-31.

    PubMed 10506258

  • Janssen YJ, Frolich M, Roelfsema F. The absorption profile and availability of a physiological subcutaneously administered dose of recombinant human growth hormone (GH) in adults with GH deficiency. Br J Clin Pharmacol. 1999 Mar;47(3):273-8. doi: 10.1046/j.1365-2125.1999.00892.x.

    PubMed 10215751

  • Drake WM, Howell SJ, Monson JP, Shalet SM. Optimizing gh therapy in adults and children. Endocr Rev. 2001 Aug;22(4):425-50. doi: 10.1210/edrv.22.4.0438.

    PubMed 11493578

  • De Muinck Keizer-Schrama S, Rikken B, Hokken-Koelega A, Wit JM, Drop S. Comparative effect of two doses of growth hormone for growth hormone deficiency. The Dutch Growth Hormone Working Group. Arch Dis Child. 1994 Jul;71(1):12-8. doi: 10.1136/adc.71.1.12.

    PubMed 8067786

  • Soliman AT, abdul Khadir MM. Growth parameters and predictors of growth in short children with and without growth hormone (GH) deficiency treated with human GH: a randomized controlled study. J Trop Pediatr. 1996 Oct;42(5):281-6. doi: 10.1093/tropej/42.5.281.

    PubMed 8936959

  • Rikken B, van Doorn J, Ringeling A, Van den Brande JL, Massa G, Wit JM. Plasma levels of insulin-like growth factor (IGF)-I, IGF-II and IGF-binding protein-3 in the evaluation of childhood growth hormone deficiency. Horm Res. 1998 Sep;50(3):166-76. doi: 10.1159/000023268.

    PubMed 9762006

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CinnaTropin® and Nordilet® in people with Idiopathic Growth Hormone Deficiency, run by Cinnagen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Height velocity (time frame: three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03223025, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in