AzTrials
AzTrials

Growth Hormone DeficiencyPhase 4NCT02976675

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

A Phase 4 study testing PEG-somatropin in people with Growth Hormone Deficiency, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 24 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 3 to 18 years
Conditions the study is for
Growth Hormone Deficiency
What is being tested?
PEG-somatropin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
24 sitesChina
Study dates
Jan 2015to Jun 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Subjects are diagnosed as GHD before starting treatment, according to medical history, clinical symptoms and signs, GH provocation tests and imaging and other examinations:
  • 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;
  • Height velocity (HV) ≤5.0 cm / yr;
  • GH provocative tests (with two drugs of different mechanism of action) confirmed plasma GH peak <10.0 ng / ml;
  • 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.

Who cannot join

  • 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;
Show all 10Show fewer
  • 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.

Trial locations and contacts

24 sites in 1 country.

Xiaohua Feng contact

13610794989

fengxiaohua@gensci-china.com

24 sites in 1 country

China24 sites, 24 recruiting

  • Jishuitan Hospital of Beijing City

    Beijing

    Recruiting

  • First People's Hospital of Changzhou City

    Changzhou, Jiangsu

    Recruiting

  • Children's Hospital of Chengdu city

    Chengdu, Sichuan

    Recruiting

  • People's Hospital of Cixi City

    Cixi, Zhejiang

    Recruiting

  • Maternal and Child Health Hospital of Guiyang City

    Guiyangtou, Guizhou

    Recruiting

  • Maternal and Child Health Hospital of Hainan province

    Haikou, Hainan

    Recruiting

  • First People's Hospital

    Hangzhou, Zhejiang

    Recruiting

  • Maternal and Child Health Hospital of Anhui province

    Hefei, Anhui

    Recruiting

  • Peoples' hospital of Inner Mongolia Autonomous Region

    Inner Mongolia Autonomous Region

    Recruiting

  • First People's Hospital of Jiaxing City

    Jiaxing, Zhejiang

    Recruiting

  • Jinhua Central Hospital

    Jinhua, Zhejiang

    Recruiting

  • Second Hospital of Lanzhou University

    Lanzhou, Gansu

    Recruiting

  • First People's Hospital of Lianyungang City

    Lianyungang, Jiangsu

    Recruiting

  • First People's Hospital of Lu'an City

    Lu'an, Anhui

    Recruiting

  • Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Recruiting

  • Jiangsu Provincial Hospital of Chinese Traditional medicine

    Nanjingkou, Jiangsu

    Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu

    Recruiting

  • General Hospital of Ningxia Medical University

    Ningxia Autonomous Region

    Recruiting

  • Children's Hospital of Fudan University

    Shanghai

    Feihong Luo, Doctor, 18017590900, luo_fh@163.com

    Recruiting

  • Hebei Provincial People's Hospital

    Shijiazhuang, Hebei

    Recruiting

  • Suzhou City Hospital

    Suzhou, Jiangsu

    Recruiting

  • Maternal and Child Health Hospital of Tai'an city

    Tai’an, Shandong

    Recruiting

  • Maternal and Child Health Hospital of Hubei province

    Wuhan, Hubei

    Recruiting

  • First Affiliated Hospital of Henan University of Science and Technology

    Zhengzhou, Henan

    Recruiting

Other trials in China

About this study

Official title: Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG Somatropin

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.

Being tested
PEG-somatropin
Medical subject headings
Dwarfism, Pituitary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEG-somatropinBiological

    Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks

  • PEG-somatropinBiological

    Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks

Study groups in NCT02976675
Study groupRoleWhat they receive
PEG-somatropinExperimentalPegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks
Receives: Biological: PEG-somatropin
PEG-somatropin per two weeksExperimentalPegylated 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
Receives: Biological: PEG-somatropin
Jintropin AQActive comparatorJintropin AQ, injection, 30IU/10 mg/3ml/cartridge, 0.25mg/kg/w, once per day for 26 weeks
Receives: Biological: PEG-somatropin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ht SDSca

    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

    Measured: Baseline, 4,12,26 weeks after initiating treatment

Secondary outcomes (5)

  1. Ht SDSBA

    Calculate by formula

    Measured: Baseline, 4,12,26 weeks after initiating treatment

  2. Yearly growth velocity

    Calculate by formula

    Measured: Baseline, 4,12,26 weeks after initiating treatment

  3. IGF-1SDS

    Calculate by formula

    Measured: Baseline, 4,12,26 weeks after initiating treatment

  4. IGF-1/IGFBP-3 molar ratio

    Calculate by formula

    Measured: Baseline, 4,12,26 weeks after initiating treatment

  5. Bone age

    Calculate by formula

    Measured: Baseline, 4,12,26 weeks after initiating treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2016 (estimated)
  2. Study startJan 2015
  3. Primary completionJun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02976675
Sponsor's protocol ID
GenSci 004 CT-4
Status last verified
Nov 2016
First submitted
24 Nov 2016
Last updated
16 Jun 2017
Results posted
No
Data monitoring committee
No

Publications

  • Sun C, Lu B, Liu Y, Zhang Y, Wei H, Hu X, Hu P, Zhao Q, Liu Y, Ye K, Wang K, Gu Z, Liu Z, Ye J, Zhang H, Zhu H, Jiang Z, Liu Y, Wan N, Yan C, Yin J, Ying L, Huang F, Yin Q, Xi L, Luo F, Cheng R. 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. Front Endocrinol (Lausanne). 2021 Nov 25;12:779365. doi: 10.3389/fendo.2021.779365. eCollection 2021.

    PubMed 34899612

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PEG-somatropin in people with Growth Hormone Deficiency, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 24 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaohua Feng (13610794989, fengxiaohua@gensci-china.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ht SDSca (time frame: Baseline, 4,12,26 weeks after initiating treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02976675, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in