Small for Gestational Age InfantPhase 3NCT03245333
A Study of Recombinant Human Growth Hormone Injection for Short Children With Small for Small for Gestational Age(SGA)
A Phase 3 study testing Recombinant Human Growth Hormone Injection in people with Small for Gestational Age Infant, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 5 sites in China.
Trial summary
According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short SGA children, further to evaluate the efficacy and safety of the treatment of short SGA children. Read more about this study
- Who is it for?
- Ages 24 to 90 years
- Conditions the study is for
- Small for Gestational Age Infant
- What is being tested?
- Recombinant Human Growth Hormone Injection
- 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 2014to Dec 2017
- 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 24 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of full-term 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).
- 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 participating in the study.
- Bone age<Chronological age+1.
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- Normal glucose regulation：Fasting blood-glucose < 5.6mmol/L, and 2 hours postprandial blood-glucose < 7.8mmol/L.
- Gestational age was 37 to 42 weeks.
- The subjects and their guardians signed informed consent.
Who cannot join
- Subjects with Liver and renal insufficiency (ALT > 1.5 times of upper limit of normal value, Cr> upper limit of normal value).
- Patients are positive for antibodies to hepatitis B core (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 growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome and growth hormone receptor deficiency.
- Subjects who have received the treatment of GH.
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- Subjects took part in other clinical trial study within 3 months.
- Children who have treated with other hormone (such as gonadal hormone and glucocorticoids etc, continuous administration of more than a month) and that may affect growth hormone secretion or action including oxygen male dragon, growth hormone releasing hormone, etc. 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, 5 recruiting
- Recruiting
Beijing Children's Hospital, Capital Medical University
Beijing
- Recruiting
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
- Recruiting
The first affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
- Recruiting
Shanghai Children's Hospital
Shanghai
- Recruiting
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: Phase Ⅲ Clinical Study of Recombinant Human Growth Hormone Injection (JINTOPIN AQ) for Short Children With Small for Gestational Age(SGA)
According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short SGA children, further to evaluate the efficacy and safety of the treatment of short SGA children.
- Conditions
- Small for Gestational Age Infant
- Being tested
- Recombinant Human Growth Hormone Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Growth Hormone InjectionDrug
Also called rhGH Injection
Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.
Recombinant Human Growth Hormone InjectionDrug
Also called rhGH Injection
Stage 2: After completing phase 1, patients are administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd weeks to the final height.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1-experimental group | Experimental | JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）, for 52 weeks. Receives: Drug: Recombinant Human Growth Hormone Injection |
| Stage 1-negative control | Other | observed only for 52 weeks. Receives: Drug: Recombinant Human Growth Hormone Injection |
| Stage 2-experimental group | Experimental | After completing the stage 1, experimental groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height. Receives: Drug: Recombinant Human Growth Hormone Injection |
| Stage 2-negative control | Other | After completing the stage 1, negative control groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height. Receives: Drug: Recombinant Human Growth Hormone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of height standard deviation score for chronological age (△Ht SDSCA)
△Ht SDS= Ht SDSafter treatment - Ht SDSbaseline Ht SDSCA = (height - reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint )
Measured: 52 weeks
Secondary outcomes (10)
Height（Ht）at the end of treatment
Measured: Stage 1：52 weeks
Height（Ht）at the end of treatment
Measured: Stage 2：Every 52 weeks, up to 3 years
Annualized height velocity (HV)
Measured: Stage 1：52 weeks
Annualized height velocity (HV)
Measured: Stage 2：Every 52 weeks, up to 3 years
Bone age maturation
Measured: Stage 1：52 weeks
Bone age maturation
Measured: Stage 2：Every 52 weeks, up to 3 years
Mole ratio of IGF-1 and IGFBP-3
Measured: Stage 1：52 weeks
Mole ratio of IGF-1 and IGFBP-3
Measured: Stage 2：Every 52 weeks, up to 3 years
IGF-1 standard deviation score (SDS)
Measured: Stage 1：52 weeks
IGF-1 standard deviation score (SDS)
Measured: Stage 2：Every 52 weeks, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study startDec 2014
- Primary completionDec 2017 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245333
- Sponsor's protocol ID
- GenSci 030 CT-III
- Status last verified
- Jul 2017
- First submitted
- 18 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 Ⅲ Clinical Study of Recombinant Human Growth Hormone Injection (JINTOPIN AQ) for Short Children With Small for Gestational Age(SGA)
- ClinicalTrials.gov ID
- NCT03245333
- Acronym / sponsor ID
- GenSci 030 CT-III
- Conditions
- Small for Gestational Age Infant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- 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 2014 (actual)
- Primary completion
- Dec 2017 (estimated)
- First posted
- 10 Aug 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.
According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short SGA children, further to evaluate the efficacy and safety of the treatment of short SGA children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stage 1-experimental group | Experimental | Drug: Recombinant Human Growth Hormone InjectionJINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）, for 52 weeks. |
| Stage 1-negative control | Other | Drug: Recombinant Human Growth Hormone Injectionobserved only for 52 weeks. |
| Stage 2-experimental group | Experimental | Drug: Recombinant Human Growth Hormone InjectionAfter completing the stage 1, experimental groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height. |
| Stage 2-negative control | Other | Drug: Recombinant Human Growth Hormone InjectionAfter completing the stage 1, negative control groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height. |
Who may qualify
- Ages
- 24 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical diagnosis of full-term 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).
- 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 participating in the study.
Key exclusion criteria (9 listed)
- Subjects with Liver and renal insufficiency (ALT > 1.5 times of upper limit of normal value, Cr> upper limit of normal value).
- Patients are positive for antibodies to hepatitis B core (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 growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome and 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 |
|---|---|---|
| Recombinant Human Growth Hormone InjectionAlso: rhGH InjectionStage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks. | Drug | Stage 1-experimental group, Stage 1-negative control, Stage 2-experimental group, Stage 2-negative control |
| Recombinant Human Growth Hormone InjectionAlso: rhGH InjectionStage 2: After completing phase 1, patients are administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd weeks to the final height. | Drug | Stage 1-experimental group, Stage 1-negative control, Stage 2-experimental group, Stage 2-negative control |
Primary outcome
Change of height standard deviation score for chronological age (△Ht SDSCA)
Time frame: 52 weeks
△Ht SDS= Ht SDSafter treatment - Ht SDSbaseline Ht SDSCA = (height - reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint )
10 secondary outcomes
Height（Ht）at the end of treatment
Time frame: Stage 1：52 weeks
Height（Ht）at the end of treatment
Time frame: Stage 2：Every 52 weeks, up to 3 years
Annualized height velocity (HV)
Time frame: Stage 1：52 weeks
Annualized height velocity (HV)
Time frame: Stage 2：Every 52 weeks, up to 3 years
Bone age maturation
Time frame: Stage 1：52 weeks
Bone age maturation
Time frame: Stage 2：Every 52 weeks, up to 3 years
Mole ratio of IGF-1 and IGFBP-3
Time frame: Stage 1：52 weeks
Mole ratio of IGF-1 and IGFBP-3
Time frame: Stage 2：Every 52 weeks, up to 3 years
IGF-1 standard deviation score (SDS)
Time frame: Stage 1：52 weeks
IGF-1 standard deviation score (SDS)
Time frame: Stage 2：Every 52 weeks, up to 3 years
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.
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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.
5 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 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 9 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 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 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 (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?
Change of height standard deviation score for chronological age (△Ht SDSCA) (time frame: 52 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 12 Dec 2017.