Growth RetardationPhase 4NCT03290235
Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children
A Phase 4 study testing PEG-somatropin in people with Growth Retardation, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
1. To further evaluate the safety and efficacy of PEG-Somatropin in the treatment of children with growth hormone deficiency for a relatively long period 2. To explore the factors influencing the efficacy of PEG-Somatropin and to establish the height prediction model based on Chinese children with short stature, and… Read more about this study
- Who is it for?
- Ages 42 months to 15 years
- Conditions the study is for
- Growth Retardation
- 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
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to Sep 2021
- 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 42 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children has completed all visits and therapy in previous phase IV study;
- Investigators evaluate subjects could continue growth hormone therapy;
- 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
- Children with epiphyseal closure;
- Children is near the adule final height, that is, growth rate≤ 2 cm / year or bone age ≥ 14 years old for girls, bone age ≥ 16 years old for boys;
- Dysfunction of liver and kidney (ALT> 2 times the upper limit of normal, Cr> upper limit of normal);
- 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;
- Patients with diabetics;
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- Patients with congenital bone dysplasia or scoliosis;
- Patients took drugs that would influence the efficacy and safety of PEG-Somatropin after phase IV study and before screening for this extension study;
- Other conditions in which the investigator preclude enrollment into the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
TongJi hospital affiliated to TongJi medical college of HuaZhong university of Science & Teconology
Wuhan, Hubei
About this study
Official title: The Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children
- To further evaluate the safety and efficacy of PEG-Somatropin in the treatment of children with growth hormone deficiency for a relatively long period
- To explore the factors influencing the efficacy of PEG-Somatropin and to establish the height prediction model based on Chinese children with short stature, and to provide the basis and guidance for standard and reasonable long-term clinical application of PEG-Somatropin.
- Conditions
- Growth Retardation
- Being tested
- PEG-somatropin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-somatropinDrug
Also called Jintrolong®
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit
| Study group | Role | What they receive |
|---|---|---|
| PEG-somatropin-1 | Experimental | Dosage 0.2mg/kg/w Receives: Drug: PEG-somatropin |
| PEG-somatropin-2 | Experimental | Dosage 0.1-0.2mg/kg/w Receives: Drug: PEG-somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ht SDSca (Height standard deviation score for chronological age)
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, every 13 weeks until 130 weeks
Secondary outcomes (5)
Ht SDSBA (Height standard deviation score for bone age)
Measured: Baseline, every 13 weeks until 130 weeks
Yearly growth velocity
Measured: Baseline, every 13 weeks until 130 weeks
IGF-1 SDS (Standard deviation score of insulin-like growth factor-1)
Measured: Baseline, every 13 weeks until 130 weeks
Bone age
Measured: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks, 130 weeks
Near final height for some subjects
When yearly growth velocity of some subject is no more than 2cm/year.
Measured: Baseline, every 13 weeks until 130 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start1 Mar 2017
- Primary completionOct 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth RetardationStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290235
- Sponsor's protocol ID
- GenSci 045 CT-Extension Period
- Status last verified
- Sep 2017
- First submitted
- 19 Sep 2017
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hou L, Huang K, Gong C, Luo F, Wei H, Liang L, Du H, Zhang J, Zhong Y, Chen R, Chen X, Pan J, Jin X, Zeng T, Liao W, Liu D, Lan D, Zhu S, Dong Z, Ma H, Yang Y, Xiong F, Lu P, Cheng S, Gu X, Jin R, Liu Y, Wu J, Xu X, Chen L, Dong Q, Pan H, Su Z, Liu L, Luo X, Ni S, Chen Z, Hu Y, Wang C, Liu J, Liu L, Lu B, Wang X, Wang Y, Yang F, Zhang M, Cao L, Liu G, Yao H, Zhan Y, Dai M, Li G, Li L, Liu Y, Wang K, Xiao Y, Zhang X, Dong J, Gu Z, Ying L, Huang F, Liu Y, Liu Z, Ye J, Zhao D, Hu X, Jiang Z, Ye K, Zhu H, Chen S, Chen X, Wan N, Xu Z, Yin Q, Zhang H, Huang X, Yin J, Zhang H, Li P, Yin P, Fu J, Luo X. Long-term Pegylated GH for Children With GH Deficiency: A Large, Prospective, Real-world Study. J Clin Endocrinol Metab. 2023 Jul 14;108(8):2078-2086. doi: 10.1210/clinem/dgad039.
PubMed 36669772
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children
- ClinicalTrials.gov ID
- NCT03290235
- Acronym / sponsor ID
- GenSci 045 CT-Extension Period
- Conditions
- Growth Retardation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To further evaluate the safety and efficacy of PEG-Somatropin in the treatment of children with growth hormone deficiency for a relatively long period
- To explore the factors influencing the efficacy of PEG-Somatropin and to establish the height prediction model based on Chinese children with short stature, and to provide the basis and guidance for standard and reasonable long-term clinical application of PEG-Somatropin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-somatropin-1 | Experimental | Drug: PEG-somatropinDosage 0.2mg/kg/w |
| PEG-somatropin-2 | Experimental | Drug: PEG-somatropinDosage 0.1-0.2mg/kg/w |
Who may qualify
- Ages
- 42 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children has completed all visits and therapy in previous phase IV study;
- Investigators evaluate subjects could continue growth hormone therapy;
- Subjects is willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.
Key exclusion criteria (9 listed)
- Children with epiphyseal closure;
- Children is near the adule final height, that is, growth rate≤ 2 cm / year or bone age ≥ 14 years old for girls, bone age ≥ 16 years old for boys;
- Dysfunction of liver and kidney (ALT> 2 times the upper limit of normal, Cr> upper limit of normal);
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-somatropinAlso: Jintrolong®Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit | Drug | PEG-somatropin-1, PEG-somatropin-2 |
Primary outcome
Ht SDSca (Height standard deviation score for chronological age)
Time frame: Baseline, every 13 weeks until 130 weeks
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
5 secondary outcomes
Ht SDSBA (Height standard deviation score for bone age)
Time frame: Baseline, every 13 weeks until 130 weeks
Yearly growth velocity
Time frame: Baseline, every 13 weeks until 130 weeks
IGF-1 SDS (Standard deviation score of insulin-like growth factor-1)
Time frame: Baseline, every 13 weeks until 130 weeks
Bone age
Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks, 130 weeks
Near final height for some subjects
Time frame: Baseline, every 13 weeks until 130 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Derived from this study: PubMed 36669772Hou L, Huang K, Gong C, Luo F, Wei H, Liang L, Du H, Zhang J, Zhong Y, Chen R, Chen X, Pan J, Jin X, Zeng T, Liao W, Liu D, Lan D, Zhu S, Dong Z, Ma H, Yang Y, Xiong F, Lu P, Cheng S, Gu X, Jin R, Liu Y, Wu J, Xu X, Chen L, Dong Q, Pan H, Su Z, Liu L, Luo X, Ni S, Chen Z, Hu Y, Wang C, Liu J, Liu L, Lu B, Wang X, Wang Y, Yang F, Zhang M, Cao L, Liu G, Yao H, Zhan Y, Dai M, Li G, Li L, Liu Y, Wang K, Xiao Y, Zhang X, Dong J, Gu Z, Ying L, Huang F, Liu Y, Liu Z, Ye J, Zhao D, Hu X, Jiang Z, Ye K, Zhu H, Chen S, Chen X, Wan N, Xu Z, Yin Q, Zhang H, Huang X, Yin J, Zhang H, Li P, Yin P, Fu J, Luo X. Long-term Pegylated GH for Children With GH Deficiency: A Large, Prospective, Real-world Study. J Clin Endocrinol Metab. 2023 Jul 14;108(8):2078-2086. doi: 10.1210/clinem/dgad039.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PEG-somatropin in people with Growth Retardation, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site 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 3 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 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (0431-85170552, 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, every 13 weeks until 130 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 NCT03290235, 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 12 Dec 2017.