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Pediatric Growth Hormone DeficiencyPhase 3NCT04633057

A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency

A Phase 3 study testing TJ101 and NordiFlex in people with Pediatric Growth Hormone Deficiency, run by TJ Biopharma Co., Ltd. at 30 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase III, Randomized, open-label, positive-drug parallel control, Study to Evaluate the Efficacy and Safety of TJ101 in Child subject with growth hormone deficieney. Read more about this study

Who is it for?
Ages 3 to 12 years
Conditions the study is for
Pediatric Growth Hormone Deficiency
What is being tested?
TJ101 and NordiFlex
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
30 sitesChina
Study dates
25 Jan 2021to 31 Jul 2023
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 3 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Boys: 3 years ≤ boy's age ≤ 10 years；Girls: 3 years ≤ girl's age ≤ 9 years
  • Pre-pubertal children(Tanner stage I)
  • GHD confirmed by 2 different GH provocation tests with peak GH concentration below 10 ng/mL in screening or one month
  • 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)
  • Height velocity≤5.0cm/years (Including height records before at least three months)；
  • IGF-1 SDS≤-1.0
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  • Bone age (BA) is no more than two chronological age
  • 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
  • Without prior exposure to any rhGH therapy
  • 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
  • Written informed consent of the parent or legal guardian of the subject and assent of the subject (if the subject can read)

Who cannot join

  • beyond physiological dosage of glucocorticoid therapy
  • Evidence of closed epiphyses
  • 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)
  • Abnormal liver and renal function (ALT>1.5 times the upper limit of normal range and Cr exceeding the upper limit of normal range)
  • Presence of anti-hGH antibodies at screening
  • 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)]
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  • Mutations in growth hormone receptors are suspected, or any syndrome that causes insensitivity to growth hormone
  • At screening, ophthalmologic examination (including fundus microscopy) indicated increased intracranial pressure and/or retinopathy.
  • 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)
  • Diseases such as severe cardiopulmonary, blood system, malignant tumor or potential tumor (family history), or systemic infection, low immune function and mental diseases
  • Significant spinal abnormalities, including scoliosis (Cobb Angle \& GT;60 ˚), kyphosis and spina bifida.
  • 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
  • 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
  • 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)
  • The subject and/or the parent/legal guardian are likely to be non-compliant in respect to study conduct
  • Subject who has received an investigational product or has participated in a clinical study within 30 days before screening or during the clinical trials.
  • Known or suspected to be HIV positive, serologically positive for syphilis, or other chronic infectious diseases, such as AIDS, tuberculosis, hepatitis, etc
  • The history of drug, drug or alcohol abuse
  • Other conditions not considered suitable for inclusion by the researchers

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

China30 sites

  • Beijing Children's Hospital,Capital Medical University

    Beijing, Beijing Municipality

  • Children's Hospital, Capital Institute of Paediatrics

    Beijing, Beijing Municipality

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin

  • Hunan Children's Hospital

    Changsha, Hunan

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan

  • West China Second Hospital of Sichuan University

    Chengdu, Sichuan

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

  • The Third Affiliated Hospital of Sun Yet-sen University

    Guangzhou, Guangdong

  • Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • The First Affiliated Hospital of Nanhua University

    Hengyang, Hunan

  • Affiliated Hospital of Jining Medical College

    Jining, Shandong

  • Linyi Women and Children's Hospital

    Linyi, Shandong

  • Liuzhou Maternity and Children Healthcare Hospital

    Liuzhou, Guangxi

  • Taizhou First People's Hospital

    Liuzhou, Zhejiang

  • Jiangxi Provincial Children's Hospital

    Nanchang, Jiangxi

  • Children's Hospital of Nanjing Medical University

    Nanjing, Jiangsu

  • Jiangsu Provincial Maternal and Child Health Hospital

    Nanjing, Jiangsu

  • Ningbo Women & Children's Hospital

    Ningbo, Zhejiang

  • Pingxiang Maternity and Child Care Hospital

    Pingxiang, Jiangxi

  • Hainan Third People's Hospital

    Sanya, Hainan

  • Shanghai Children's Medical Center

    Shanghai, Shanghai Municipality

  • Shanghai Jiaotong University School of Medicine Ruijin Hospital

    Shanghai, Shanghai Municipality

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • Children's Hospital affiliated to Soochow University

    Suzhou, Jiangsu

  • Tangshan Women and Children's Hospital

    Tangshan, Hebei

  • Chongqing Three Gorges Central Hospital

    Wanzhou, Chongqing Municipality

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • Wuhan Children's Hospital

    Wuhan, Hubei

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia

  • Henan Children's Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Phase III, Randomized, Open-label, Positive-controlled, Multi-center Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency

A Phase III, Randomized, open-label, positive-drug parallel control, Study to Evaluate the Efficacy and Safety of TJ101 in Child subject with growth hormone deficieney.

Being tested
TJ101, NordiFlex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TJ101Drug

    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.

  • NordiFlexDrug

    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.

Study groups in NCT04633057
Study groupRoleWhat they receive
TJ101ExperimentalTJ101 1.2 mg/kg once a week for 52weeks
Receives: Drug: TJ101
NordiFlexActive comparatorNordiFlex Injection 0.034 mg/kg once a day for 52 weeks
Receives: Drug: NordiFlex

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Annualized Height velocity at 52 week

    The Annualized Height velocity at 52 week

    Measured: 52weeks after first dose

Secondary outcomes (2)

  1. change in Annualized Height velocity at 26 week (compared to Baseline value)

    Measured: 26weeks after first dose

  2. change in Annualized Height velocity at 52 week (compared to Baseline value)

    Measured: 52weeks after first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2020
  2. Study start25 Jan 2021
  3. Primary completion31 Jul 2023
  4. Study completion31 Jul 2023

Resources

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
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04633057
Sponsor's protocol ID
CTJ101PGHD301
Status last verified
Apr 2024
First submitted
12 Nov 2020
Last updated
15 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TJ101 and NordiFlex in people with Pediatric Growth Hormone Deficiency, run by TJ Biopharma Co., Ltd. at 30 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 19 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 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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?

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?

The Annualized Height velocity at 52 week (time frame: 52weeks after first dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04633057.

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 15 Apr 2024.

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