A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency
NCT ID: NCT04633057
Last Updated: 2024-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
168 participants
INTERVENTIONAL
2021-01-25
2023-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome
NCT01604161
Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency Children
NCT04513171
Evaluating the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency
NCT07126288
Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
NCT02314676
Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
NCT01495468
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TJ101
TJ101 1.2 mg/kg once a week for 52weeks
TJ101
TJ101/ Recombinant Human Somatropin Injection treatment: after screening, subjects will be randomized to receive TJ101 1.2 mg/kg once a week until 52 weeks back site, investigator evaluate effectiveness and safety.
NordiFlex
NordiFlex Injection 0.034 mg/kg once a day for 52 weeks
NordiFlex
TJ101/ Recombinant Human Somatropin Injection treatment: after screening, subjects will be randomized to receive Recombinant Human Somatropin Injection 0.034 mg/kg once a day, until 52 weeks back site, investigator evaluate effectiveness and safety.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TJ101
TJ101/ Recombinant Human Somatropin Injection treatment: after screening, subjects will be randomized to receive TJ101 1.2 mg/kg once a week until 52 weeks back site, investigator evaluate effectiveness and safety.
NordiFlex
TJ101/ Recombinant Human Somatropin Injection treatment: after screening, subjects will be randomized to receive Recombinant Human Somatropin Injection 0.034 mg/kg once a day, until 52 weeks back site, investigator evaluate effectiveness and safety.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Pre-pubertal children(Tanner stage I)
3. GHD confirmed by 2 different GH provocation tests with peak GH concentration below 10 ng/mL in screening or one month
4. Height (HT) of at least 2.0 standard deviations (SD) below the mean height for chronological age (CA) and gender according to Table of standard deviation unit values of age and height of Chinese children aged 3-12 years , (HT SDS ≤ -2.0)
5. Height velocity≤5.0cm/years (Including height records before at least three months)；
6. IGF-1 SDS≤-1.0
7. Bone age (BA) is no more than two chronological age
8. Body mass Index (BMI) must be within ±2 SD of mean BMI for the chronological age and sex according to Table of standard deviation unit values of Age and BMI of Chinese children aged 3-12 years
9. Without prior exposure to any rhGH therapy
10. For children with growth hormone deficiency that is one of its multiple pituitary hormone deficiencies, alternative therapies targeting the hypothalamus-pituitary-target gland axis must be used for at least 3 months before screening
11. Written informed consent of the parent or legal guardian of the subject and assent of the subject (if the subject can read)
Exclusion Criteria
2. Evidence of closed epiphyses
3. Any other chronic condition that can cause short stature and cannot be treated with hormone replacement therapy(Including but not limited Chronic kidney disease, malnutrition, absorption disorders, uncontrolled hypothyroidism, celiac disease, rickets and social-psychological dwarfism)
4. Abnormal liver and renal function (ALT\>1.5 times the upper limit of normal range and Cr exceeding the upper limit of normal range)
5. Presence of anti-hGH antibodies at screening
6. Concomitant administration of other treatments that may have an effect on growth such as anabolic steroids, with the exception of ADHD(attention deficit hyperactivity disorder) drug hormone replacement therapies \[thyroxine, hydrocortisone, desmopressin (DDAVP)\]
7. Mutations in growth hormone receptors are suspected, or any syndrome that causes insensitivity to growth hormone
8. At screening, ophthalmologic examination (including fundus microscopy) indicated increased intracranial pressure and/or retinopathy.
9. At screening, previous or existing intracranial tumor growth was confirmed by cranial magnetic resonance imaging (MRI) scan (using contrast agent) (MRI results up to 1 year prior to screening were acceptable)
10. Diseases such as severe cardiopulmonary, blood system, malignant tumor or potential tumor (family history), or systemic infection, low immune function and mental diseases
11. Significant spinal abnormalities, including scoliosis (Cobb Angle \& GT;60 ˚), kyphosis and spina bifida.
12. Subjects diagnosed with type 2 or type 1 diabetes who were considered to have received no standard treatment, did not follow their prescribed treatment, or exhibited poor metabolic control, or had fasting glucose \> 5.6 mmol/L twice in a row
13. Chromosomal abnormalities and medical syndromes (Turner's syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, SHOX mutations/deletions and skeletal dysplasias), with the exception of septo-optic dysplasia
14. Children with low birth weight (birth weight and/or body length are 2 SD below average according to the standard of the general Chinese population of the same gestational age and sex)
15. The subject and/or the parent/legal guardian are likely to be non-compliant in respect to study conduct
16. Subject who has received an investigational product or has participated in a clinical study within 30 days before screening or during the clinical trials.
17. Known or suspected to be HIV positive, serologically positive for syphilis, or other chronic infectious diseases, such as AIDS, tuberculosis, hepatitis, etc
18. The history of drug, drug or alcohol abuse
19. Other conditions not considered suitable for inclusion by the researchers
3 Years
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TJ Biopharma Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Children's Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Children's Hospital, Capital Institute of Paediatrics
Beijing, Beijing Municipality, China
Chongqing Three Gorges Central Hospital
Wanzhou, Chongqing Municipality, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yet-sen University
Guangzhou, Guangdong, China
Liuzhou Maternity and Children Healthcare Hospital
Liuzhou, Guangxi, China
Hainan Third People's Hospital
Sanya, Hainan, China
Tangshan Women and Children's Hospital
Tangshan, Hebei, China
Henan Children's Hospital
Zhengzhou, Henan, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Wuhan Children's Hospital
Wuhan, Hubei, China
Hunan Children's Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Nanhua University
Hengyang, Hunan, China
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Jiangsu Provincial Maternal and Child Health Hospital
Nanjing, Jiangsu, China
Children's Hospital affiliated to Soochow University
Suzhou, Jiangsu, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
Pingxiang Maternity and Child Care Hospital
Pingxiang, Jiangxi, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Affiliated Hospital of Jining Medical College
Jining, Shandong, China
Linyi Women and Children's Hospital
Linyi, Shandong, China
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
West China Second Hospital of Sichuan University
Chengdu, Sichuan, China
Taizhou First People's Hospital
Liuzhou, Zhejiang, China
Ningbo Women & Children's Hospital
Ningbo, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTJ101PGHD301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.