Growth Hormone DeficiencyPhase 4NCT02380235
Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)
A Phase 4 study testing PEG-somatropin in people with Growth Hormone Deficiency, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 12 sites in China.
Trial summary
This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 12 sitesChina
- Study dates
- Dec 2014to Jul 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, according to the medical history, clinical symptoms and signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.
- According to the height statistical data of Chinese children's physique development in nine cities in 2005,height is lower than the third percentile of growth curve of normal children with the same age and gender.
- Height velocity (HV) ≤5.0 cm/yr.
- GH stimulation test with two different mechanisms affirms that GH peak concentration of patients' plasma<10.0ng/ml.
- Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than his/her chronological age (CA).
- Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.
- Receive no prior GH treatment within 6 months.
- Sign informed consent.
Who cannot join
- People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal value, Cr> the upper limit of normal value).
- Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis Be antigen (HBeAg).
- People with known highly allergic constitution or allergy to the drug of the study.
- People with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency.
- Diabetic.
- Potential tumor patients (family history).
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- Abnormal growth and development, such as Turner syndrome, constitutional delay of growth and puberty,Laron syndrome, growth hormone receptor deficiency, girls of growth retardation without excluding abnormal chromosome.
- Subjects 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
12 sites in 1 country.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Children's Hospital Affiliated to Capital Institute of Pediatrics
Beijing, Beijing Municipality
- Recruiting
Chinese Academy of Medical Sciences &Peking Union Medical College
Beijing, Beijing Municipality
- Recruiting
First Hospital of Jilin University
Changchun, Jilin
- Recruiting
West China Second University Hospital
Chengdu, Sichuan
- Recruiting
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality
- Recruiting
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality
- Recruiting
Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine
Shanghai
- Recruiting
Affiliated Hospital, Jiangnan University
Wuxi, Jiangsu
About this study
This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad of population of children.
- Conditions
- Growth Hormone Deficiency
- 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
0.20mg/kg/w
PEG-somatropinBiological
0.12mg/kg/w
| Study group | Role | What they receive |
|---|---|---|
| PEG-somatropin | Experimental | 0.12mg/kg/w Receives: Biological: PEG-somatropin |
| PEG-Somatropin | Experimental | 0.20mg/kg/w Receives: Biological: PEG-somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ht SDSca
Ht SDSca was 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, 4,12,26 weeks after initiating treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 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
- NCT02380235
- Sponsor's protocol ID
- GenSci 004 CT-2
- Status last verified
- Jun 2017
- First submitted
- 2 Mar 2015
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)
- ClinicalTrials.gov ID
- NCT02380235
- Acronym / sponsor ID
- GenSci 004 CT-2
- Conditions
- Growth Hormone Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 5 Mar 2015 (estimated)
- 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 evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad of population of children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-somatropin | Experimental | Biological: PEG-somatropin0.12mg/kg/w |
| PEG-Somatropin | Experimental | Biological: PEG-somatropin0.20mg/kg/w |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Before starting treatment, according to the medical history, clinical symptoms and signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.
- Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.
- Receive no prior GH treatment within 6 months.
- Sign informed consent.
Key exclusion criteria (9 listed)
- People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal value, Cr> the upper limit of normal value).
- Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis Be antigen (HBeAg).
- People with known highly allergic constitution or allergy to the drug of the study.
- People with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency.
- Diabetic.
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-somatropin0.20mg/kg/w | Biological | PEG-Somatropin, PEG-somatropin |
| PEG-somatropin0.12mg/kg/w | Biological | PEG-Somatropin, PEG-somatropin |
Primary outcome
Ht SDSca
Time frame: Baseline, 4,12,26 weeks after initiating treatment
Ht SDSca was 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 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.
12 sites 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 Hormone Deficiency, 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 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 16 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 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 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?
Ht SDSca (time frame: Baseline, 4,12,26 weeks after initiating treatment). 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 16 Jun 2017.