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Trial · Interventional

Status unknownPhase 4Registry data

Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency

NCTNCT03249480 (opens ClinicalTrials.gov in a new tab)Other idGenSci 004 CT-GCX
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
900 participants (estimated)
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

China

Start
Jan 2015
Primary completion
Aug 2017 (estimated)
Completion
Not stated
First posted
15 Aug 2017
Last update posted
15 Aug 2017
Conditions
Growth Hormone Deficiency

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. Ph 4

    Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency

    NCT03249480

    Jan 2015 to est. Aug 2017 (primary)

Registry summary

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

To Evaluate the safety and efficacy of PEG Somatropin in the treatment of children with growth hormone deficiency, as well as to study the dosage of PEG Somatropin.

Interventions

  • PEG-somatropinBiological

Arms1

  • Experimental

    PEG-somatropin

    30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Ht SDSca (Height Standard Deviation Score for Chronological Age)

    Time frame · Baseline

    Registry description

    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. Change of yearly growth velocity from baseline to 26 weeks

    Time frame · Baseline, 26 weeks after initiating treatment

    Registry description

    Height velocity calculate by formula

  3. Ht SDSca

    Time frame · 26 weeks after initiating treatment

    Registry description

    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

Secondary outcomes(4)

  1. Ht SDSBA (Height Standard Deviation Score for Bone Age)

    Time frame · Baseline,26 weeks after initiating treatment

  2. IGF-1 SDS (IGF-1 Standard Deviation Score)

    Time frame · Baseline,26 weeks after initiating treatment

  3. IGFBP-3 SDS (IGFBP-3 Standard Deviation Score)

    Time frame · Baseline,26 weeks after initiating treatment

  4. Skeletal maturity

    Time frame · Baseline,26 weeks after initiating treatment

    Registry description

    Skeletal maturity=(Bone Age at 26 weeks-Bone Age at baseline)/treatment duration

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.

A trial that is still running, or that stopped early, may post results later.

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

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2022

Polyethylene glycol recombinant human growth hormone in Chinese prepubertal slow-growing short children: doses reported in a multicenter real-world study.

Chen et al. 2022BMC endocrine disorderscited by 14

PMID 35945517PMC9364582DOI 10.1186/s12902-022-01101-8PUB-35945517

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
All
Age
from 3 Years up to 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosed as GHD before starting treatment, according to medical history, clinical symptoms and signs, GH provocation tests and imaging and other examinations: 1. According to statistical height data of physical development of Chinese children in nine cities in 2005, the height is lower than 3rd percentile growth curve of the same age, same sex normal children; 2. Height velocity (HV) ≤5.0 cm / yr; 3. GH provocative tests (with two drugs of different mechanism of action) confirmed plasma GH peak \<10.0 ng / ml; 4. bone age for girl≤9 years old, for Boy≤10 years old, bone age is one year or more later than the actual age, that is the actual age - bone age ≥ 1 year; * Before puberty (Tanner I stage), age≥3 years old, male or female; * Have not received hormone therapy within 6 months; * Subjects is willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent. Exclusion Criteria: * Dysfunction of liver and kidney (ALT\> 2 times the upper limit of normal, Cr\> upper limit of normal); * Patients positive for hepatitis B c-antibody (HBcAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg); * Patients with known hypersensitivity to PEG Somatropin or Somatropin or any other components of the study product; * Patients with severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases; * Potential cancer patients (family history); * Patients with diabetics; * Patients with other growth disorders, such as Turner's syndrome, sexual physical delayed puberty, Laron syndrome, growth hormone receptor deficiency, girls with slowly growing who did not rule out chromosomal abnormalities; * Patients with congenital bone dysplasia or scoliosis; * Subjects took part in other clinical trial study during 3 months; * Other conditions in which the investigator preclude enrollment into the study.

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