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COMPLETEDPHASE3

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

NCT04633057•TJ Biopharma Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

3 - 12 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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
+9 more criteria

Locations (30)

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

Liuchow, 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

Key Dates

Start Date

January 25, 2021

Primary Completion Date

July 31, 2023

Completion Date

July 31, 2023

Last Updated

April 15, 2024

Enrollment

168

ACTUAL participants

Conditions

Pediatric Growth Hormone Deficiency

Interventions

TJ101

DRUG

NordiFlex

DRUG

A Bioequivalence Study of Two Different PEG-rhGH Preparations.

NCT06331026

Pediatric Growth Hormone Deficiency (PGHD)

View study

TERMINATEDPHASE2/PHASE3

Versartis Trial in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) to Assess Long-Acting Growth Hormone (Somavaratan, VRS-317)

NCT02413138

Pediatric Growth Hormone DeficiencyGrowth Disorders

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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