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Growth Hormone DeficiencyPhase 4NCT03249480

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
28 sitesChina
Study dates
Jan 2015to Aug 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

  • 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;
  • 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

28 sites in 1 country.

Xiaohua Feng contact

13610794989

fengxiaohua@gensci-china.com

28 sites in 1 country

China28 sites, 28 recruiting

  • China-Japan Friendship Hospital

    Beijing

    Recruiting

  • Peking University Third Hospital

    Beijing

    Recruiting

  • Hunan Children's Hospital

    Changsha, Hunan

    Recruiting

  • Dalian Children's Hospital

    Dalian, Liaoning

    Recruiting

  • Fuzhou Children s Hospital

    Fuzhou, Fujian

    Recruiting

  • Sun Yat-Sen Memorial Hospital

    Guangzhou, Guangdong

    Recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Recruiting

  • Anhui Provincial Children's Hospital

    Hefei, Anhui

    Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

    Recruiting

  • Kunming Children's Hospital

    Kunming, Yunnan

    Recruiting

  • Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

    Recruiting

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan

    Recruiting

  • Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region

    Nanjing, Jiangsu

    Recruiting

  • Nanjing Children's Hospital

    Nanjing, Jiangsu

    Recruiting

  • Shenzhen Children's Hospital

    Shenzhen

    Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiangzhuang, Hebei

    Recruiting

  • Children's Hospital of Hebei Province

    Shijiazhuang, Hebei

    Recruiting

  • Children's Hospital of Soochow University

    Suzhou, Jiangsu

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin

    Recruiting

  • Union Hospital, Tongji Medical College, HUST

    Wuhan, Hubei

    Recruiting

  • Wuhan Children's Hospital

    Wuhan, Hubei

    Recruiting

  • Wuxi Children's Hospital

    Wuxi, Jiangsu

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

    Recruiting

  • Xi'an Children's Hospital

    Xi’an, Shanxi

    Recruiting

  • Xuzhou Children's Hpspital

    Xuzhou, Jiangsu

    Recruiting

  • Children's Hospital of Zhengzhou

    Zhengzhou, Henan

    Recruiting

  • Henan Provincal People's Hospital

    Zhengzhou, Henan

    Recruiting

  • The First Affiliated Hospital of Henan University of TCM

    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, Open-label, Phase IV Clinical Trial With Different Administration Dosage of PEG Somatropin

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.

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

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

Study groups in NCT03249480
Study groupRoleWhat they receive
PEG-somatropinExperimental30IU/10 mg/3ml/kit, 0.1-0.2mg /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 (Height Standard Deviation Score for Chronological Age)

    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

  2. Change of yearly growth velocity from baseline to 26 weeks

    Height velocity calculate by formula

    Measured: Baseline, 26 weeks after initiating treatment

  3. 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: 26 weeks after initiating treatment

Secondary outcomes (4)

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

    Measured: Baseline,26 weeks after initiating treatment

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

    Measured: Baseline,26 weeks after initiating treatment

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

    Measured: Baseline,26 weeks after initiating treatment

  4. Skeletal maturity

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

    Measured: Baseline,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 posted15 Aug 2017
  2. Study startJan 2015
  3. Primary completionAug 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03249480
Sponsor's protocol ID
GenSci 004 CT-GCX
Status last verified
Jul 2017
First submitted
24 Jul 2017
Last updated
15 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chen J, Zhong Y, Wei H, Chen S, Su Z, Liu L, Liang L, Lu P, Chen L, Chen R, Ni S, Wang X, Li L, Wang Y, Xu X, Xiao Y, Yao H, Liu G, Jin R, Cao B, Wu D, Su C, Li W, Qin M, Li X, Luo X, Gong C. Polyethylene glycol recombinant human growth hormone in Chinese prepubertal slow-growing short children: doses reported in a multicenter real-world study. BMC Endocr Disord. 2022 Aug 9;22(1):201. doi: 10.1186/s12902-022-01101-8.

    PubMed 35945517

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 28 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 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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 (Height Standard Deviation Score for Chronological Age) (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT03249480, 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 15 Aug 2017.

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