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Clinical Trials in China / NCT07126288
Starting soon Phase 2/3

Evaluating the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency

NCT07126288 · tracked via the Priya Life Science China tracker
Sponsor
Shenzhen Kexing Pharmaceutical Co., Ltd.
Phase
Phase 2/3
Started
2025-08-31
Last updated
2025-08-22

Condition(s) studied

Growth Hormone Deficiency in ChildrenGrowth Hormone Deficiency (GHD)Growth Hormone

Investigational drug(s) / intervention(s)

GB08Norditropin NordiFlex

GB08: In Phase II trial, eligible PGHD patients will receive GB08 0.4mg/kg, 0.8mg/kg, or 1.2mg/kg subcutaneous injection, once a week for 24 weeks. In Phase III trial, the individuals will receive GB08 subcutaneous injection, once a week for 52 weeks. The dose of GB08 at this stage will be determined by the outcomes of Phase II.

Norditropin NordiFlex: Norditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 24 weeks (Phase II) or 52 weeks (Phase III)

Study summary

This study aims to evaluate the efficacy and safety of GB08 injection compared to Norditropin NordiFlex in pediatric patients with growth hormone deficiency (PGHD). It seeks to resolve the following questions:

* 1: Does GB08 injection demonstrate comparable efficacy in treating PGHD at 24 weeks compared to Norditropin NordiFlex?
* 2: Which dose (0.4 mg/kg, 0.8 mg/kg, and 1.2 mg/kg) of GB08 injection best balances efficacy and safety in treating PGHD at 24 weeks?
* 3: Does GB08 injection maintain its efficacy in treating PGHD at 52 weeks compared to Norditropin NordiFlex? To achieve these, GB08 injection will be compared to Norditropin NordiFlex to see if it provides a more effective or safer treatment option for PGHD.

This is a Phase II/III, Seamless, Multicenter, Randomized, Open-Label, Positive-Comparator Controlled Clinical Trial with two stages. Stage 1 answers questions #1 and #2 by comparing the efficacy and safety of GB08 injection and Norditropin NordiFlex intervention among PGHD at 24 weeks. It involves four groups (n=16 each): GB08 0.4 mg/kg, GB08 0.8 mg/kg, GB08 1.2 mg/kg, and Norditropin NordiFlex 0.035 mg/kg. GB08 and Norditropin NordiFlex will be administered once weekly and once daily, respectively. The primary outcome measurement is annualized height velocity (AHV) at 24 weeks. Other measurements include growth hormone levels, safety parameters, immunogenicity markers, and pharmacokinetic/pharmacodynamic profiles.

The optimal GB08 dose will be further investigated in Stage 2, which answers question #3. At this stage, PGHD patients will randomly receive either GB08 injection or Norditropin NordiFlex intervention for 52 weeks (n=102 for each). After that, the efficacy and safety of GB08 will also be detected.

Eligibility

Sex
ALL
Min age
3 Years
Max age
11 Years
Healthy volunteers
No
Inclusion Criteria: 1\. Diagnosed with Growth Hormone Deficiency (GHD) based on medical history, clinical symptoms and signs, GH stimulation tests, and imaging studies. The participant must meet the following: 1. Absolute height 2 standard deviations (SD) below the mean height of children of the same age and sex, according to the standardized growth curves for children and adolescents in China (0-18 years old) published in 2009. 2. Annualized height velocity (AHV) ≤ 5.0 cm/year, calculated from measurement of 6 to 18 months before screening. 3. GH peak ≤ 10 ng/ml proved by two different GH stimulation tests within a year before screening. 4. Bone age lagging at least 1 year behind actual age (bone age assessment within the past 6 months before screening), with girls \< 10 years old and boys \< 11 years old. 2\. Aging \> 3 years and ≤ 10 years (girls) or ≤ 11 years (boys) based on birth date; Tanner stage I (testicular volume \< 4 ml for boys and no palpable breast tissue for girls) 3. Uniform short stature with normal intellectual development. 4. IGF-1 levels below the mean for children and adolescents of the same age and sex, at least 1 SD below (IGF-1 SDS ≤ -1.0). 5\. Body mass index (BMI) within ±2 SD of the mean BMI for children and adolescents of the same age and sex. 6\. For subjects with GHD as part of multiple pituitary hormone deficiencies, must be stable for ≥1 month, as determined by the investigator. 7\. Guardians understand and sign the Informed Consent Form (ICF). If the participant is ≥8 years old, they must also sign the ICF. For participants \<8 years old who can express consent, their consent must be recorded. Exclusion Criteria: 1. History of systematic growth-promoting therapy, including growth hormone and sex hormones. 2. Severe allergic constitution or known allergy to growth hormone or its excipients, such as mannitol, lysine, or sodium chloride. 3. Closed epiphyses. 4. Other types of growth disorders such as idiopathic short stature, Turner syndrome, Noonan syndrome, Prader-Willi syndrome, and Russell-Silver syndrome. 5. Short stature due to other causes, such as intrauterine growth restriction, familial short stature, thyroid hormone deficiency, adrenal insufficiency, antidiuretic hormone deficiency, celiac disease, rickets, psychological factors, chronic kidney disease, infections, or trauma. 6. Any clinically significant abnormalities that may affect growth or growth assessment; subjects with liver or kidney dysfunction (ALT \> 1.5 times upper limit of normal, creatinine \> upper limit of normal), chronic diseases (malnutrition, fasting blood glucose ≥ 126 mg/dL or HbA1c ≥ 6.5%), diabetes, severe cardiac, pulmonary, hematological, or systemic infections, immunodeficiency, psychiatric disorders, or congenital malformations. 7. Infectious diseases, such as hepatitis B, hepatitis C, AIDS, syphilis, or tuberculosis (HBV surface antigen-positive subjects must undergo HBV DNA testing; HCV antibody-positive subjects must undergo HCV RNA testing; if HBV DNA or HCV RNA \> detection limit, they are excluded). 8. Use of corticosteroids or other steroids within the past 12 months, such as long-term steroid use for asthma. 9. History of pituitary or hypothalamic tumors, or other intracranial tumors on MRI; history of leukemia, lymphoma, or other malignancies. 10. History of radiation therapy or chemotherapy. 11. Congenital intracranial hypertension. 12. Femoral head slipped epiphysis (SCFE). 13. Spinal scoliosis \> 15°. 14. Participation in any other drug clinical trial within the past 3 months (as a subject). 15. Other factors deemed unsuitable for participation in the study by the investigator.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Xiamen Maternal and Child Health Hospital Xiamen Fujian
Nanyang Central Hospital Nanyang Henan
The First Affiliated Hospital of Nanyang Medical College Nanyang Henan
The Third Affiliated Hospital of Xinxiang Medical University Xinxiang Henan
Wuhan Children's Hospital Wuhan Hubei
Suzhou University Children's Hospital Suzhou Jiangsu
Jiangxi Children's Hospital Nanchang Jiangxi
Pingxiang Maternal and Child Health Hospital Pingxiang Jiangxi
The First Hospital of Jilin University Changchun Jilin
Linyi Maternal and Child Health Hospital Linyi Shandong
Chengdu Women's and Children's Central Hospital Chengdu Sichuan
Meishan People's Hospital Meishan Sichuan
The Second People's Hospital of Yibin Yibin Sichuan
Zhejiang Provincial People's Hospital Hangzhou Zhejiang
Children's Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
Ningbo Women's and Children's Hospital Ningbo Zhejiang

More Shenzhen Kexing Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07126288 on ClinicalTrials.gov ↗ ← All trials in China