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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 : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
I-Mab Biopharma Co. Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Pediatric Growth Hormone Deficiency Drug: TJ101 Drug: NordiFlex Phase 3

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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
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
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.




Primary Outcome Measures :
  1. The Annualized Height velocity at 52 week [ Time Frame: 52weeks after first dose ]
    The Annualized Height velocity at 52 week


Secondary Outcome Measures :
  1. change in Annualized Height velocity at 26 week (compared to Baseline value) [ Time Frame: 26weeks after first dose ]
  2. change in Annualized Height velocity at 52 week (compared to Baseline value) [ Time Frame: 52weeks after first dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Boys: 3 years ≤ boy's age ≤ 10 years;Girls: 3 years ≤ girl's age ≤ 9 years
  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:

  1. beyond physiological dosage of glucocorticoid therapy
  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

Information from the National Library of Medicine

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


Contacts
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Contact: Xiaoping Luo 13387522645 xpluo@sina.com
Contact: Wei Wu 13871186026 wuweir11@163.com

Locations
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Sponsors and Collaborators
I-Mab Biopharma Co. Ltd.
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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: April 5, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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