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Completed

NCT Number: NCT01495468

Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children

This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation).

All the subjects were randomized into two groups, test group (PEG somatorpin) and control group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled in control group. Considering the case loss during the clinical study, 20% of the patients were added in each of the group, that is 240 children were in test group and 120 children were in control group, totally 360 children were enrolled in the phase III clinical study.

Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the evaluation would be made when the treatment is finished.

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. Subjects have a height less than two standard deviations (SD) below the median height for individuals of he same age or height,the growth velocity (CV≤4.0 cm/yr),GH peak concentration <7.0ng/ml in two difference provocative tests, Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 2 year less than his/her chronological age (CA)
  • be in preadolescence (Tanner stage 1) and have a CA > 3 years
  • have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV.
  • receive no prior GH treatment.
  • sign informed consent

Exclusion criteria

  • 1. patients positive for hepatitis B e-antibody (HBeAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)
  • 2.Known hypersensitivity to Somatropin or any other components of the study product.
  • 3. severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases
  • 4. with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome
  • 5. Subjects took part in other clinical trial study during 3 months.
  • 6. Other conditions which in the opinion of the investigator preclude enrollment into the study.

Treatment and study plan

PEG-somatropin

Biological

drug:pegylated somatropin 0.2mg/(kg.w), once per week for 6 months drug: Jintropin AQ, 0.25mg/(kg.w), once per day for 6 months

Other names: recombinant human growth hormone, peglyated growth hormone, PEG-GH

Primary outcomes

  1. yearly growth velocity

    Time frame: 6 months

    growth velocity add as GV was the primary outcome measure

Secondary outcomes

  1. Ht SDSca

    Time frame: 6 months

    Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age

  2. IGF-l

    Time frame: 6 months

  3. IGFBP-3

    Time frame: 6 months

  4. bone maturity

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Capital Medical University
  • Children's Hospital of Fudan University
  • First Affiliated Hospital, Sun Yat-Sen University
  • The First Hospital of Jilin University
  • Tongji Hospital

Registry information

Official study title

Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient：A Multicenter, Randomized, Open-label, Controlled Phase Ⅲ Clinical Trial

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 20, 2011
Registry last updated
Jul 31, 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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