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Completed

NCT Number: NCT03221933

A Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for SGA

To preliminary assess the efficacy and safety of recombinant human growth hormone injection on the treatment of small for gestational age (SGA), and determine the best dose.

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Key information

Conditions

Small for Gestational Age Infant

Age range

24 month–90 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of small for gestational age, SGA.
  • Chronological age between 2-6.5 years in girls and 2-7.5 years in boys. Both genders.
  • Prepubertal stage (Tanner I).
  • Without catch-up growth in two years after birth.
  • Height was lower than the mean -2SD of the values of normal children of the same age and gender when participating in the study.
  • A GH peak concentration >10µg/L in a provocative test within a year before participate in the study.
  • Bone age<Chronological age+1.
  • Normal glucose regulation：Fasting blood-glucose < 5.6mmol/L and 2-hour postprandial blood glucose< 7.8mmol/L.
  • Gestational age≥Gestational age≥ 36weeks + 4days.
  • Never accepted growth hormone treatment.
  • The subjects and their guardians signed informed consent.

Exclusion criteria

  • Subjects with Liver and renal insufficiency (ALT > 2 times of upper limit of normal value, Cr> upper limit of normal value).
  • Patients with positive for antibodies to hepatitis B core (anti-HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)。
  • Known highly allergic constitution or allergic to the test drug.
  • Subjects with diabetes, severe cardiopulmonary and pulmonary disease, and hematological diseases, malignant tumors, or systemic infection, immunocompromised patients and patients with psychosis.
  • Subjects with other types of abnormal growth and development, such as Turner syndrome, constitutional delay of puberty, Laron syndrome, growth hormone receptor deficiency.
  • Subjects who have received the treatment of Somatropin or took part in other clinical trial study within 3 months.
  • Other conditions which in the opinion of the investigator preclude enrollment into the study.

Treatment and study plan

Somatropin Injection low dose group

Biological

0.23mg/kg /wk，inject for seven divided doses

Somatropin Injection high dose group

Biological

0.46mg/kg /wk，inject for seven divided dose

Primary outcomes

  1. Height standard deviation score for chronological age (Ht SDSCA)

    Time frame: 26 weeks

    HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)

  2. Height standard deviation score for chronological age (Ht SDSCA)

    Time frame: 52 weeks

    HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)

  3. Height standard deviation score for chronological age (Ht SDSCA)

    Time frame: 78 weeks

    HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)

  4. Height standard deviation score for chronological age (Ht SDSCA)

    Time frame: 104 weeks

    HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)

Secondary outcomes

  1. ΔHtSDSCA

    Time frame: 26 weeks， 52 weeks，78 weeks and 104 weeks

    Change in height SDS for chronological age (Ht SDSCA)

  2. Change in HV

    Time frame: 26 weeks， 52 weeks，78 weeks and 104 weeks

    Change in annualized height velocity (HV)

  3. Change in bone age maturation

    Time frame: 26 weeks， 52 weeks，78 weeks and 104 weeks

  4. Change in mole ratio of IGF-1 and IGFBP-3

    Time frame: 26 weeks， 52 weeks，78 weeks and 104 weeks

  5. Change in PAH

    Time frame: 26 weeks， 52 weeks，78 weeks and 104 weeks

    Change in prediction of adult height (PAH)

  6. Change in obesity prevalence

    Time frame: 26 weeks， 52 weeks，78 weeks and 104 weeks

  7. Change in overweight

    Time frame: 26 weeks， 52 weeks，78 weeks and 104 weeks

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Beijing Children's Hospital
  • Shanghai Children's Hospital
  • The Children's Hospital of Zhejiang University School of Medicine
  • The First Affiliated Hospital with Nanjing Medical University
  • Tongji Hospital

Registry information

Official study title

Phase Ⅱ Clinical Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for Gestational Age(SGA)

Important dates

Study start
2009
Primary completion
2014
First posted
Jul 19, 2017
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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