Small for Gestational Age InfantPhase 2NCT03221933
A Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for SGA
A Phase 2 study testing Somatropin Injection low dose group and Somatropin Injection high dose group in people with Small for Gestational Age Infant, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 5 sites in China.
Trial summary
To preliminary assess the efficacy and safety of recombinant human growth hormone injection on the treatment of small for gestational age (SGA), and determine the best dose. Read more about this study
- Who is it for?
- Ages 24 to 90 months
- Conditions the study is for
- Small for Gestational Age Infant
- What is being tested?
- Somatropin Injection low dose group and Somatropin Injection high dose group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesChina
- Study dates
- Dec 2009to Dec 2014
- Phase
- Phase 2
- 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 24 to 90 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of small for gestational age, SGA.
- Chronological age between 2-6.5 years in girls and 2-7.5 years in boys. Both genders.
- Prepubertal stage (Tanner I).
- Without catch-up growth in two years after birth.
- Height was lower than the mean -2SD of the values of normal children of the same age and gender when participating in the study.
- A GH peak concentration >10µg/L in a provocative test within a year before participate in the study.
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- Bone age<Chronological age+1.
- Normal glucose regulation：Fasting blood-glucose < 5.6mmol/L and 2-hour postprandial blood glucose< 7.8mmol/L.
- Gestational age≥Gestational age≥ 36weeks + 4days.
- Never accepted growth hormone treatment.
- The subjects and their guardians signed informed consent.
Who cannot join
- Subjects with Liver and renal insufficiency (ALT > 2 times of upper limit of normal value, Cr> upper limit of normal value).
- Patients with positive for antibodies to hepatitis B core (anti-HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)。
- Known highly allergic constitution or allergic to the test drug.
- Subjects with diabetes, severe cardiopulmonary and pulmonary disease, and hematological diseases, malignant tumors, or systemic infection, immunocompromised patients and patients with psychosis.
- Subjects with other types of abnormal growth and development, such as Turner syndrome, constitutional delay of puberty, Laron syndrome, growth hormone receptor deficiency.
- Subjects who have received the treatment of Somatropin or took part in other clinical trial study within 3 months.
- Other conditions which in the opinion of the investigator preclude enrollment into the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Beijing Children's Hospital of Capital Medical University
Beijing
Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
The first affiliated Hospital with Nanjing Medical Universit
Nanjing, Jiangsu
Shanghai Children's Hospital
Shanghai
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: Phase Ⅱ Clinical Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for Gestational Age(SGA)
To preliminary assess the efficacy and safety of recombinant human growth hormone injection on the treatment of small for gestational age (SGA), and determine the best dose.
- Conditions
- Small for Gestational Age Infant
- Being tested
- Somatropin Injection low dose group, Somatropin Injection high dose group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatropin Injection low dose groupBiological
0.23mg/kg /wk，inject for seven divided doses
Somatropin Injection high dose groupBiological
0.46mg/kg /wk，inject for seven divided dose
| Study group | Role | What they receive |
|---|---|---|
| Somatropin Injection low dose group | Experimental | 0.23mg/kg /wk，inject for seven divided doses. Receives: Biological: Somatropin Injection low dose group; Biological: Somatropin Injection high dose group |
| Somatropin Injection high dose group | Experimental | 0.46mg/kg /wk，inject for seven divided doses. Receives: Biological: Somatropin Injection low dose group; Biological: Somatropin Injection high dose group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height standard deviation score for chronological age (Ht SDSCA)
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
Measured: 26 weeks
Height standard deviation score for chronological age (Ht SDSCA)
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
Measured: 52 weeks
Height standard deviation score for chronological age (Ht SDSCA)
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
Measured: 78 weeks
Height standard deviation score for chronological age (Ht SDSCA)
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
Measured: 104 weeks
Secondary outcomes (7)
ΔHtSDSCA
Change in height SDS for chronological age (Ht SDSCA)
Measured: 26 weeks， 52 weeks，78 weeks and 104 weeks
Change in HV
Change in annualized height velocity (HV)
Measured: 26 weeks， 52 weeks，78 weeks and 104 weeks
Change in bone age maturation
Measured: 26 weeks， 52 weeks，78 weeks and 104 weeks
Change in mole ratio of IGF-1 and IGFBP-3
Measured: 26 weeks， 52 weeks，78 weeks and 104 weeks
Change in PAH
Change in prediction of adult height (PAH)
Measured: 26 weeks， 52 weeks，78 weeks and 104 weeks
Change in obesity prevalence
Measured: 26 weeks， 52 weeks，78 weeks and 104 weeks
Change in overweight
Measured: 26 weeks， 52 weeks，78 weeks and 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study startDec 2009
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small for Gestational Age InfantStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tongji Hospital, Beijing Children's Hospital, The First Affiliated Hospital with Nanjing Medical University, Shanghai Children's Hospital, The Children's Hospital of Zhejiang University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Xiaoping Luo, Principal investigator, Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221933
- Sponsor's protocol ID
- GenSci 030 CT-II
- Status last verified
- Jul 2017
- First submitted
- 16 Jul 2017
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Phase Ⅱ Clinical Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for Gestational Age(SGA)
- ClinicalTrials.gov ID
- NCT03221933
- Acronym / sponsor ID
- GenSci 030 CT-II
- Conditions
- Small for Gestational Age Infant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tongji Hospital, Beijing Children's Hospital, The First Affiliated Hospital with Nanjing Medical University, Shanghai Children's Hospital, The Children's Hospital of Zhejiang University School of Medicine
- Study start
- Dec 2009 (actual)
- Primary completion
- Dec 2014 (actual)
- First posted
- 19 Jul 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 preliminary assess the efficacy and safety of recombinant human growth hormone injection on the treatment of small for gestational age (SGA), and determine the best dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Somatropin Injection low dose group | Experimental | Biological: Somatropin Injection low dose group, Biological: Somatropin Injection high dose group0.23mg/kg /wk，inject for seven divided doses. |
| Somatropin Injection high dose group | Experimental | Biological: Somatropin Injection low dose group, Biological: Somatropin Injection high dose group0.46mg/kg /wk，inject for seven divided doses. |
Who may qualify
- Ages
- 24 to 90 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Clinical diagnosis of small for gestational age, SGA.
- Chronological age between 2-6.5 years in girls and 2-7.5 years in boys. Both genders.
- Prepubertal stage (Tanner I).
- Without catch-up growth in two years after birth.
- Height was lower than the mean -2SD of the values of normal children of the same age and gender when participating in the study.
Key exclusion criteria (7 listed)
- Subjects with Liver and renal insufficiency (ALT > 2 times of upper limit of normal value, Cr> upper limit of normal value).
- Patients with positive for antibodies to hepatitis B core (anti-HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)。
- Known highly allergic constitution or allergic to the test drug.
- Subjects with diabetes, severe cardiopulmonary and pulmonary disease, and hematological diseases, malignant tumors, or systemic infection, immunocompromised patients and patients with psychosis.
- Subjects with other types of abnormal growth and development, such as Turner syndrome, constitutional delay of puberty, Laron syndrome, growth hormone receptor deficiency.
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 |
|---|---|---|
| Somatropin Injection low dose group0.23mg/kg /wk，inject for seven divided doses | Biological | Somatropin Injection high dose group, Somatropin Injection low dose group |
| Somatropin Injection high dose group0.46mg/kg /wk，inject for seven divided dose | Biological | Somatropin Injection high dose group, Somatropin Injection low dose group |
Primary outcome
Height standard deviation score for chronological age (Ht SDSCA)
Time frame: 26 weeks
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
Height standard deviation score for chronological age (Ht SDSCA)
Time frame: 52 weeks
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
Height standard deviation score for chronological age (Ht SDSCA)
Time frame: 78 weeks
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
Height standard deviation score for chronological age (Ht SDSCA)
Time frame: 104 weeks
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
7 secondary outcomes
ΔHtSDSCA
Time frame: 26 weeks， 52 weeks，78 weeks and 104 weeks
Change in HV
Time frame: 26 weeks， 52 weeks，78 weeks and 104 weeks
Change in bone age maturation
Time frame: 26 weeks， 52 weeks，78 weeks and 104 weeks
Change in mole ratio of IGF-1 and IGFBP-3
Time frame: 26 weeks， 52 weeks，78 weeks and 104 weeks
Change in PAH
Time frame: 26 weeks， 52 weeks，78 weeks and 104 weeks
Change in obesity prevalence
Time frame: 26 weeks， 52 weeks，78 weeks and 104 weeks
Change in overweight
Time frame: 26 weeks， 52 weeks，78 weeks and 104 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
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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.
Xiaoping Luo principal investigator
Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Somatropin Injection low dose group and Somatropin Injection high dose group in people with Small for Gestational Age Infant, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 5 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 11 inclusion and 7 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: finished, 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 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height standard deviation score for chronological age (Ht SDSCA) (time frame: 26 weeks). The study lists 4 primary outcomes in all. 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 12 Dec 2017.