Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature

NCT01778023 | Completed Phase 3 Results

• 3 other identifiers: GH-3899U1111-1125-47902015-002613-30
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 8

Brief Summary

This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.

Conditions

Growth Disorder; Idiopathic Short Stature

Outcome Measures

Primary Outcomes (1)

• Height Velocity (Ht-V)

  Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk.

  After 6 months of treatment

Secondary Outcomes (6)

• Change in Ht-SDS (Height Standard Deviation Score)

  After 6 months of treatment.

• Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I)

  After 6 months of treatment.

• Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3)

  After 6 months of treatment.

• Change in Bone Age

  After 6 months of treatment.

• Occurrence of Adverse Events

  Throughout the trial (12 months)

Study Arms (2)

hGH:12months treatment

EXPERIMENTAL

Drug: somatropin

hGH: 6 month un-treatment + 6 month treatment

ACTIVE COMPARATOR

Drug: somatropin

Interventions

somatropin DRUG

A weekly dosage of 0.469 mg of somatropin per kg of body weight per week will be injected subcutaneously (under the skin) in the evening in 7 days per week.

hGH: 6 month un-treatment + 6 month treatment; hGH:12months treatment

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent obtained from subject's parents or legally acceptable representative before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
• Pre-pubertal status (males aged from 4 to 11 \[both inclusive\], females aged from 4 to 9 \[both inclusive\]): an absence of breast development in females (Tanner 1 only) and testicular volume below 4 mL in males
• Growth hormone level above 10 ng/mL following a stimulation test (test result within 6 months from screening can be used)
• Height below 3 percentile
• Bone age below or equal to 12 year
• Epiphyses confirmed as open in patients at least 10 years or more of age

You may not qualify if:

• Known presence of one or more pituitary hormone deficiencies (ACTH (adrenocorticotropic hormone), ADH (antidiuretic hormone), FSH (follicle-stimulating hormone), LH (luteinising hormone), TSH (thyroid-stimulating hormone))
• Known primary hypothyroidism, adrenal insufficiency or hypogonadism (treated or untreated)
• Specific types of growth failure including, but not limited to, known chromosomal abnormalities associated with growth failure and altered sensitivity to growth hormone
• Bone age is advanced over chronological age more than 3 years
• Active malignancy, CNS (central nervous system) trauma, active chemotherapy or radiation therapy for neoplasia
• Prior history of intracranial hypertension
• Hypertrophic cardiomyopathy

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (8)

Novo Nordisk Investigational Site

Busan, 614-735, South Korea

Location

Novo Nordisk Investigational Site

Daegu, 700-721, South Korea

Location

Novo Nordisk Investigational Site

Seoul, 02841, South Korea

Location

Novo Nordisk Investigational Site

Seoul, 03722, South Korea

Location

Novo Nordisk Investigational Site

Seoul, 137-701, South Korea

Location

Novo Nordisk Investigational Site

Seoul, 138-736, South Korea

Location

Novo Nordisk Investigational Site

Seoul, 150-713, South Korea

Location

Novo Nordisk Investigational Site

Suwon, 443-721, South Korea

Location

Related Publications (2)

• Safety and Efficacy Evaluation of Human Growth Hormone (GH) Therapy in Patients with Idiopathic Short Stature (ISS) in Korea - a Randomized Controlled Trial; Min Ho Jung, Byung-Kyu Suh, Cheol Woo Ko et al.; 028-042-GH-Pediatrics (posters) ENDO meeting 2016, Boston Massachusetts

  RESULT

• Jung MH, Suh BK, Ko CW, Lee KH, Jin DK, Yoo HW, Hwang JS, Chung WY, Han HS, Prusty V, Kim HS. Efficacy and Safety Evaluation of Human Growth Hormone Therapy in Patients with Idiopathic Short Stature in Korea - A Randomised Controlled Trial. Eur Endocrinol. 2020 Apr;16(1):54-59. doi: 10.17925/EE.2020.16.1.54. Epub 2019 Oct 15.

  PMID: 32595770 DERIVED

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Growth Disorders

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 29, 2013
• Study Start: January 17, 2013
• Primary Completion: December 17, 2014
• Study Completion: December 17, 2014
• Last Updated: June 2, 2017
• Results First Posted: October 5, 2016

Record last verified: 2017-05

Locations

KR (8)