Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency Children

  • STATUS
    Recruiting
  • End date
    Dec 22, 2023
  • participants needed
    400
  • sponsor
    Xiamen Amoytop Biotech Co., Ltd.
Updated on 22 March 2022
somatomedin c
stimulation test
somatropin
short stature

Summary

This is a multicenter, randomized, open-labeled, positive controlled phase 2&3 combined study to evaluate the safety and efficacy of weekly Y-shape pegylated somatropin, compared to daily somatropin (Norditropin®), in prepubertal, treatment-naive children with growth hormone deficiency.

Description

This multicenter, randomized, open-labeled, positive controlled study is divided into two stages. The first one is aimed to exploit the optimal dose of Y-shape pegylated somatropin, while the second one is aimed to confirm the efficacy and safety of the study drug. A total of 400 prepubertal children with growth hormone deficiency were expected to enrolled. Subjects will firstly undergo a 52 weeks treatment, and then followed for 5 weeks.

Details
Condition Growth Hormone Deficiency
Treatment Norditropin, Norditropin®, Y-shape pegylated somatropin
Clinical Study IdentifierNCT04513171
SponsorXiamen Amoytop Biotech Co., Ltd.
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of GHD confirmed by two different GH stimulation tests, defined as a peak of GH level of <10.0 ng/ml, determined with a validated assay. Bone age (BA) at least 2 years less than the chronological age. Growth velocity less than 5.0 cm/year. Impaired HT defined as at least 2.0 standard deviations (SD) below of the mean height for chronological age and sex (HT SDS<-2.0)
Prepubertal (Tanner Ⅰ) males and females by physical examination, aged older than 3 years and younger than10 years for girls and 11 years for boys
Short stature with normal intelligence
Baseline IGF-1 level below the median IGF-1 level standardized for age and sex
Written, signed informed consent of the parent(s) or legal guardian(s) of the subject and written assent of the subject (if the subject is 8 years old or above)

Exclusion Criteria

Prior exposure to growth promotion treatment, such as recombinant human growth hormone or gonadal hormones, for more than 1 month
Known hypersensitivity to somatropin or excipients, such as mannitol, lysine, sodium chloride
Children with closed epiphyses
Short stature etiologies other than GHD, such as idiopathic short stature, Turner syndrome, Prader-Willi syndrome, Russell-Silver syndrome, born small for gestational age regardless of GH status
Other causes of short stature such as hypothyroidism, adrenocortical hormone deficiency, antidiuretic hormone deficiency
Any medical conditions and/or presence that may affect growth velocity such as liver dysfunction, kidney dysfunction, malnutrition, diabetes mellitus, severe dysfunction in major organ such as heart, sever systemic infections, severe immune dysfunction, mental disorders, and other congenital malformations
Suffering from chronic infectious diseases such as chronic hepatitis B, AIDS or tuberculosis
Receiving non-physiological adrenal corticosteroids
Confirmed pituitary and/or hypothalamic malignance by MRI within one year prior to screening. History or presence of any other malignance disease, any evidence of present tumor growth
Evidence of congenital intracranial hypertension
Evidence of slipped capital femoral epiphysis
Evidence of scoliosis over 15°
Participation in any other trial of an investigational agent within 3 months prior to screening
Any other conditions which in the opinion of the investigator precluded enrollment into the study
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