Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT02976675Other idGenSci 004 CT-4

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Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 600 participants (estimated)
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
China
Start: Jan 2015
Primary completion: Jun 2017 (estimated)
Completion: Not stated
First posted: 29 Nov 2016 (estimated)
Last update posted: 16 Jun 2017
Conditions: Growth Hormone Deficiency

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2015201620172018

Ph 4
Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency
NCT02976675
Jan 2015 to est. Jun 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 Injection in the treatment of children with growth hormone deficiency, as well as to study the feasibility of extending the dosing intervals (once per two weeks) of PEG Somatropin Injection.

Interventions

PEG-somatropinBiological
PEG-somatropinBiological

Arms3

Experimental
PEG-somatropin
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks
Experimental
PEG-somatropin per two weeks
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks
Active comparator
Jintropin AQ
Jintropin AQ, injection, 30IU/10 mg/3ml/cartridge, 0.25mg/kg/w, once per day for 26 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

Ht SDSca
Time frame · Baseline, 4,12,26 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(5)

Ht SDSBA
Time frame · Baseline, 4,12,26 weeks after initiating treatment
Registry description
Calculate by formula
Yearly growth velocity
Time frame · Baseline, 4,12,26 weeks after initiating treatment
Registry description
Calculate by formula
IGF-1SDS
Time frame · Baseline, 4,12,26 weeks after initiating treatment
Registry description
Calculate by formula
IGF-1/IGFBP-3 molar ratio
Time frame · Baseline, 4,12,26 weeks after initiating treatment
Registry description
Calculate by formula
Bone age
Time frame · Baseline, 4,12,26 weeks after initiating treatment
Registry description
Calculate by formula

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

Indexing hint: Randomized controlled trial · 2021

Corrected

Reduced Effectiveness and Comparable Safety in Biweekly vs. Weekly PEGylated Recombinant Human Growth Hormone for Children With Growth Hormone Deficiency: A Phase IV Non-Inferiority Threshold Targeted Trial.

Sun et al. 2021Frontiers in endocrinologycited by 11

PMID 34899612PMC8655095DOI 10.3389/fendo.2021.779365PUB-34899612

CC BY

Download PDF Read the notice

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: * Subjects are 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; * Subjects 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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