A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency
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ClinicalTrials.gov Identifier: NCT04633057 |
Recruitment Status :
Recruiting
First Posted : November 18, 2020
Last Update Posted : July 7, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pediatric Growth Hormone Deficiency | Drug: TJ101 Drug: NordiFlex | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 165 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | January 25, 2021 |
Estimated Primary Completion Date : | February 28, 2023 |
Estimated Study Completion Date : | March 31, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: TJ101
TJ101 1.2 mg/kg once a week for 52weeks
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Drug: 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. |
Active Comparator: NordiFlex
NordiFlex Injection 0.034 mg/kg once a day for 52 weeks
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Drug: 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. |
- The Annualized Height velocity at 52 week [ Time Frame: 52weeks after first dose ]The Annualized Height velocity at 52 week
- change in Annualized Height velocity at 26 week (compared to Baseline value) [ Time Frame: 26weeks after first dose ]
- change in Annualized Height velocity at 52 week (compared to Baseline value) [ Time Frame: 52weeks after first dose ]

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Ages Eligible for Study: | 3 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- 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)]
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633057
Contact: Xiaoping Luo | 13387522645 | xpluo@sina.com | |
Contact: Wei Wu | 13871186026 | wuweir11@163.com |

Responsible Party: | I-Mab Biopharma Co. Ltd. |
ClinicalTrials.gov Identifier: | NCT04633057 |
Other Study ID Numbers: |
CTJ101PGHD301 |
First Posted: | November 18, 2020 Key Record Dates |
Last Update Posted: | July 7, 2021 |
Last Verified: | July 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dwarfism, Pituitary Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine |
Hypopituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |