Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT03223025Other idGH.CIN.MR93Other idIRCT201409064920N5

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 30 participants (actual)
Sponsor: Cinnagen · Industry
Design: Randomized · Open label (no masking)
Countries: Not stated
Start: 9 Mar 2016
Primary completion: 4 Feb 2017
Completion: 4 Feb 2017
First posted: 19 Jul 2017
Last update posted: 31 Aug 2023
Conditions: Idiopathic Growth Hormone Deficiency

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201620172018

Ph 3
Comparing Efficacy and Safety of CinnaGen Biosimilar Growth Hormone (CinnaTropin®) Versus Nordilet in Children With Idiopathic Growth Hormone Deficiency
NCT03223025
9 Mar 2016 to 4 Feb 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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®.

Interventions

CinnaTropin®Drug
Nordilet®Drug

Arms2

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.
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Height velocity
Time frame · three months
Registry description
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 outcomes(6)

Height
Time frame · three months
Registry description
Changes in height is measured in both treatment arms.
Weight
Time frame · three months
Registry description
Changes in height is measured in both treatment arms.
Bone Age
Time frame · six months
Registry description
Bone age is determined by wrist x-ray radiography in both treatment arms
HSDS
Time frame · three months
Registry description
Height standard deviation score is calculated to compare height based on reference population.
HVSDS
Time frame · three months
Registry description
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;
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Observational study · 1999

9 results

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.

Gasperi et al. 1999The Journal of clinical endocrinology and metabolismcited by 24

PMID 10443652DOI 10.1210/jcem.84.8.5904PUB-10443652

Rights unknown9 results

Source link See results (9)

More studies

2 studies on this page

Indexing hint: Clinical trial · 2003

Effects of one year of recombinant human growth hormone (GH) therapy on cardiac mass and function in children with classical GH deficiency.

Shulman et al. 2003The Journal of clinical endocrinology and metabolismcited by 32

PMID 12970269DOI 10.1210/jc.2003-030030PUB-12970269

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 1999

The absorption profile and availability of a physiological subcutaneously administered dose of recombinant human growth hormone (GH) in adults with GH deficiency.

Janssen et al. 1999British journal of clinical pharmacologycited by 10

PMID 10215751PMC2014216DOI 10.1046/j.1365-2125.1999.00892.xPUB-10215751

Rights unknown

Source link

Eligibility

Who could join, as posted.

Sex: All
Age: from 4 Years up to 16 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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