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Growth Hormone DeficiencyPhase 4NCT02908958

Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency

A Phase 4 study testing PEG-somatropin in people with Growth Hormone Deficiency, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 22 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 The sponsor has not verified this record for over two years, so it may be out of date.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 Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children. 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
900 participants
Where
22 sitesChina
Study dates
Nov 2014to 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

  • Before starting treatment, the child is diagnosed as GHD according to medical history,clinical symptoms and signs, GH provocation tests and imaging examinators and other examinators.
  • According to the height statistical data of Chinese children's physical development in nine cities in 2015, the height of the child is lower than the third percentile of normal children's growth curve in the same age and same gender.
  • Height velocity (HV) ≤5.0 cm/yr.
  • GH provocation tests with two different mechanisms showed that GH peak concentration of the child is < 10.0ng/ml.
  • Bone age (BA) ≤9 years in girls or ≤ 10 years in boys, and the BA is 1 year less than the CA.
  • Prepuberty status (Tanner I stage), age ≥3 years old, girls and boys are acceptable.
  • The child did not receive the treatment of growth hormone within 6 months.
  • Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, and they sign informed consent.

Who cannot join

  • The child is dysfunction of liver and kidney (ALT) 2 times of the upper limit of normal value, Cr> the upper limit of normal value).
  • The child has positive hepatitis B core antibody (HBc), hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg).
  • The child is known as hypersensitivity to PEG Somatropin.
  • The child has severe cardiopulmonary, hematological diseases, malignant tumors, general infection or immunodeficiency diseases.
  • The child has potential tumor (family history).
  • The child has diabetics.
Show all 9Show fewer
  • The child has abnormal growth and development, such as Turner's syndrome, constitutional delay of growth and puberty, Laron syndrome, growth hormone receptor deficiency, short stature girls with potential chromosomal abnormalities.
  • The child took part in other clinical trials within 3 months.
  • Other conditions are excluded when the investigator preclude the enrollment into the study.

Trial locations and contacts

22 sites in 1 country.

Xiaohua Feng contact

13610794989

fengxiaohua@gensci-china.com

22 sites in 1 country

China22 sites, 22 recruiting

  • Children's Hospital of Changchun

    Changchun, Jilin

    Jing Liu, MD

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Xingxing Zhang, MD

    Recruiting

  • Xiangya Hospital, Central South University

    Changsha, Hunan

    Lizhi Cao, MD

    Recruiting

  • Chengdu Women and Children's Central Hospital

    Chengdu, Sichuan

    Xinran Cheng, MD

    Recruiting

  • Southwest Hospital, Third Military Medical University

    Chongqing

    Wei Liao, MD

    Recruiting

  • Guangzhou Women and Children's Medical Center

    Guangzhou, Guangdong

    Li Liu, MD

    Recruiting

  • The Third Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Shunye Zhu, MD

    Recruiting

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang

    Mingjuan Dai, MD

    Recruiting

  • The Children's Hospital ,Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Junfen Fu, PhD

    Recruiting

  • Zhejiang Provincial Hospital of Traditional Chinese Medcine Hospital

    Hangzhou, Zhejiang

    Qin Dong

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

    Xiaoming Luo, MD

    Recruiting

  • Harbin Children's Hospital

    Harbin, Heilongjiang

    Hong Yu, MD

    Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

    Deyun Liu, MD

    Recruiting

  • Qilu Children's Hospital of Shandong University

    Jinan, Shandong

    Dongmei Zhao, MD

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong

    Junhua Dong, MD

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Dan Lan, MD

    Recruiting

  • Ningbo Women and Children's Hospital

    Ningbo, Zhejiang

    Jianping Zhang, MD

    Recruiting

  • Shanghai Children's Medical Center

    Shanghai

    Xiaodong Huang, MD

    Recruiting

  • Shaoxing Second Hospital

    Shaoxing, Zhejiang

    Manyan Zhang, MD

    Recruiting

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Xianjiang Jin, MD

    Recruiting

  • Wuhu No.1 People's Hospital

    Wuhu, Anhui

    Jiayan Pan, MD

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Qun Lian, MD

    Recruiting

Other trials in China

About this study

Official title: Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial II

To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children.

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

    High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.

  • PEG-somatropinBiological

    Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.

Study groups in NCT02908958
Study groupRoleWhat they receive
PEG-somatropinExperimentalLow dose group, PEG Somatropin 0.14mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
Receives: Biological: PEG-somatropin
PEG-SomatropinExperimentalHigh dose group, PEG Somatropin 0.2mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
Receives: Biological: PEG-somatropin

What is being measured

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

  1. The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA)

    HtSDSCA = (Height at the evaluated time point- the mean value of normal children in the same gender and same age) / the height SD of normal children in the same gender and same age

    Measured: 26 weeks

Secondary outcomes (4)

  1. HtSDSBA

    HtSDSBA = (height at the evaluated time point-the mean value of normal children in the same gender and same age) / height SD of normal children in the same bone age and same gender

    Measured: 26 weeks

  2. Annual height velocity

    Annual Growth Velocity (cm/yr) = 12×(Height at the end of treatment-Height at the beginning of treatment)/the treatment duration (month)

    Measured: 26 weeks

  3. Standard Deviation Score of serum IGF-1 (IGF-1 SDS)

    IGF-1 SDS = (actual concentration of IGF-1-the median of IGF-1 concentration of normal children in the age and same gender) / SD of IGF-1 concentration of normal children in the same gender and same age

    Measured: 26 weeks

  4. Bone Maturation

    Bone Maturation = (BA at the end of treatment-BA at the beginning of treatment)/ the treatment duration (Year)

    Measured: 26 weeks

Timeline

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

  1. First posted21 Sep 2016 (estimated)
  2. Study startNov 2014
  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
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02908958
Sponsor's protocol ID
GenSci 004 CT-Zhejiang
Status last verified
Sep 2016
First submitted
19 Sep 2016
Last updated
14 Jun 2017
Results posted
No
Data monitoring committee
No

Publications

  • Jiang Z, Chen X, Dong G, Lou Y, Zhang J, Cheng X, Pan J, Liao W, Wu J, Huang X, Jin X, Liu D, Zeng T, Zhu S, Dong Q, Luo X, Lan D, Cao L, Zhang X, Liu J, Dai M, Zhang M, Liu L, Dong J, Zhao D, Ni S, Fu J. Short-term efficacy and safety of a lower dose of polyethylene glycol recombinant human growth hormone in children with growth hormone deficiency: A randomized, dose-comparison study. Front Pharmacol. 2022 Aug 11;13:955809. doi: 10.3389/fphar.2022.955809. eCollection 2022.

    PubMed 36034802

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 22 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 9 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 14 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 22 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?

The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA) (time frame: 26 weeks). 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 NCT02908958, 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 14 Jun 2017.

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