DwarfismPhase 3NCT03535415
A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Short Stature Children Due to Chronic Kidney Disease Before Transplantation
A Phase 3 study testing Recombinant Human Growth Hormone Injection (rhGH) in people with Dwarfism, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 12 sites in China.
Trial summary
This study aims to evaluate the efficacy and safety of recombinant human growth hormone injection in short stature children due to chronic kidney disease before transplantation. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Dwarfism
- What is being tested?
- Recombinant Human Growth Hormone Injection (rhGH)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 12 sitesChina
- Study dates
- 25 Jun 2018to Sep 2021
- Phase
- Phase 3
- 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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed informed consent of the subjects or the legal guardian.
- Subjects and guardian are willing and able to cooperate to complete scheduled visits,treatment plans and laboratory tests and other procedures.
- Diagnosed as chronic kidney disease.
- Glomerular filtration rate (GFR) <75ml/per min/1.73m2.
- After the treatment and adjustment of hypertension, anemia, metabolic acidosis, malnutrition, renal osteopathy, hypothyroidism, etc..
- Chronological age: ≥2years and ≤14years.
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- Height Standard Deviation Score(HtSDS) ≤-2SD for chronological age.
- Bone age: girls≤10 years; boys≤11years.
- Pre-pubertal (Tanner Stage I ) patients.
- No history of growth hormone treatment.
Who cannot join
- Subjects with abnormal liver functions.
- Subjects positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests.
- After adjustment heart function,Cardiac ejection fraction(EF) <50%.
- Subjects with highly allergic constitution or allergy to proteins or investigational product or its excipient.
- Subjects with systemic chronic disease or general infection or mental disease.
- Subjects with diabetes or impaired fasting glucose.
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- Subjects with tumor or potential tumor.
- Subjects who are using glucocorticoid or immunosuppressant.
- Other causes for growth retardation.
- Inability to obtain accurate height measurements.
- Subjects who took part in other clinical trials within 3 months.
- Concomitant administration of other treatment that may have an effect on growth within 3 months.
- Other conditions which are unsuitable for this study in the opinion of the investigator.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Beijing Children's Hospital, Capital Medical University
Beijing
Ying Shen
- Recruiting
Children's hospital capital institute of pediatrics
Beijing
Chaoying Chen
- Recruiting
Peking university first hospital
Beijing
Huijie Xiao
- Recruiting
Children's hospital of Chongqing medical university
Chongqing
Mo Wang
- Recruiting
Fuzhou general hospital of Nanjing military command
Fuzhou, Fujian
Zihua Yu
- Recruiting
The Children's Hospital ,Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jianhua Mao
- Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Yufeng Li
- Recruiting
Children's Hospital of Fudan University
Shanghai
Hong Xu
- Recruiting
Children's Hospital of Shanghai
Shanghai
Wenyan Huang
- Recruiting
Shengjing hospital of chian medical university
Shenyang, Liaoning
Yubin Wu
- Recruiting
Tongji medical college huazhong university of science & technology
Wuhan, Hubei
Jianhua Zhou
- Recruiting
The first affiliated hospital of zhengzhou university
Zhengzhou, Henan
Jianjiang Zhang
About this study
Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Short Stature Children Due to Chronic Kidney Disease Before Transplantation
This study aims to evaluate the efficacy and safety of recombinant human growth hormone injection in short stature children due to chronic kidney disease before transplantation.
- Conditions
- Dwarfism
- Being tested
- Recombinant Human Growth Hormone Injection (rhGH)
- Medical subject headings
- Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Growth Hormone Injection (rhGH)Drug
rhGH 0.05mg/kg/d by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| rhGH Injection | Experimental | rhGH 0.05mg/kg/d by subcutaneous injection Receives: Drug: Recombinant Human Growth Hormone Injection (rhGH) |
| Non-treatment control group | No intervention | Only follow-up without treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of height standard deviation score of chronological age before and after treatment (ΔHT SDS)
Measured: 52 weeks，104 weeks
Secondary outcomes (4)
Growth velocity
365.25*（height at the time of assessment -height at baseline）/duration of treatment(days)
Measured: 12 months, 24 months
Bone maturation ( bone age/ chronological age: BA/CA)
Measured: 12 months, 24 months
IGF-1 (Insulin-like growth factor 1) SDS
Measured: 12 months, 24 months
IGF-1/IGFBP-3 molar ratio
Measured: 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start25 Jun 2018
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DwarfismStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Fudan University, Beijing Children's Hospital, Shanghai Children's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The Children's Hospital of Zhejiang University School of Medicine, Children's Hospital of The Capital Institute of Pediatrics, Peking University First Hospital, Fuzhou General Hospital, The First Affiliated Hospital of Zhengzhou University, Shengjing Hospital, Children's Hospital of Chongqing Medical University, Huazhong University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Hong Xu, PhD, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535415
- Sponsor's protocol ID
- GenSci GH AQ CT-CKD
- Status last verified
- Nov 2018
- First submitted
- 28 Apr 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Short Stature Children Due to Chronic Kidney Disease Before Transplantation
- ClinicalTrials.gov ID
- NCT03535415
- Acronym / sponsor ID
- GenSci GH AQ CT-CKD
- Conditions
- Dwarfism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Fudan University, Beijing Children's Hospital, Shanghai Children's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The Children's Hospital of Zhejiang University School of Medicine, Children's Hospital of The Capital Institute of Pediatrics, Peking University First Hospital, Fuzhou General Hospital, The First Affiliated Hospital of Zhengzhou University, Shengjing Hospital, Children's Hospital of Chongqing Medical University, Huazhong University of Science and Technology
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 24 May 2018 (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.
This study aims to evaluate the efficacy and safety of recombinant human growth hormone injection in short stature children due to chronic kidney disease before transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhGH Injection | Experimental | Drug: Recombinant Human Growth Hormone Injection (rhGH)rhGH 0.05mg/kg/d by subcutaneous injection |
| Non-treatment control group | No intervention | –Only follow-up without treatment |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Signed informed consent of the subjects or the legal guardian.
- Subjects and guardian are willing and able to cooperate to complete scheduled visits,treatment plans and laboratory tests and other procedures.
- Diagnosed as chronic kidney disease.
- Glomerular filtration rate (GFR) <75ml/per min/1.73m2.
- After the treatment and adjustment of hypertension, anemia, metabolic acidosis, malnutrition, renal osteopathy, hypothyroidism, etc..
Key exclusion criteria (13 listed)
- Subjects with abnormal liver functions.
- Subjects positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests.
- After adjustment heart function,Cardiac ejection fraction(EF) <50%.
- Subjects with highly allergic constitution or allergy to proteins or investigational product or its excipient.
- Subjects with systemic chronic disease or general infection or mental disease.
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 |
|---|---|---|
| Recombinant Human Growth Hormone Injection (rhGH)rhGH 0.05mg/kg/d by subcutaneous injection | Drug | rhGH Injection |
Primary outcome
The change of height standard deviation score of chronological age before and after treatment (ΔHT SDS)
Time frame: 52 weeks，104 weeks
4 secondary outcomes
Growth velocity
Time frame: 12 months, 24 months
Bone maturation ( bone age/ chronological age: BA/CA)
Time frame: 12 months, 24 months
IGF-1 (Insulin-like growth factor 1) SDS
Time frame: 12 months, 24 months
IGF-1/IGFBP-3 molar ratio
Time frame: 12 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
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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.
Hong Xu, PhD principal investigator
Children's Hospital of Fudan University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Human Growth Hormone Injection (rhGH) in people with Dwarfism, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 12 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 10 inclusion and 13 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 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 of chronological age before and after treatment (ΔHT SDS) (time frame: 52 weeks，104 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2018.