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Clinical Trial NCT07126288 for Growth Hormone Deficiency in Children, Growth Hormone Deficiency (GHD), Growth Hormone is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Evaluating the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency Phase 2, Phase 3 268 Randomized Pediatric Open-Label
Clinical Trial NCT07126288 is designed to study Treatment for Growth Hormone Deficiency in Children, Growth Hormone Deficiency (GHD), Growth Hormone. This Phase 2 Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 31 August 2025 until the study accrues 268 participants. Led by Shenzhen Kexing Pharmaceutical Co., Ltd., this study is expected to complete by 23 December 2028. The latest data from ClinicalTrials.gov was last updated on 22 August 2025.
Brief 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 ef...
Detailed Description
This is a multicenter, randomized, open-label, positive-controlled Phase II/III seamless design clinical study evaluating the efficacy and safety of GB08 injection in pediatric patients with growth hormone deficiency (PGHD). It aims to compare the efficacy and safety of GB08 injection with Norditropin NordiFlex in PGHD patients, thereby benefiting this population. This study involves two parts: Phase II and Phase III...Show More
Official Title
A Phase II/III, Seamless, Multicenter, Randomized, Open-Label, Positive-Comparator Controlled Clinical Trial to Evaluate the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency
Conditions
Growth Hormone Deficiency in ChildrenGrowth Hormone Deficiency (GHD)Growth HormonePublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- KXZY-GB08-201
NCT ID Number
Start Date (Actual)
2025-08-31
Last Update Posted
2025-08-22
Completion Date (Estimated)
2028-12-23
Enrollment (Estimated)
268
Study Type
Interventional
PHASE
Phase 2
Phase 3
Phase 3
Status
Not yet recruiting
Keywords
growth hormone deficiency
annualized height velocity
growth hormone
clinical trial
GB08 injection
annualized height velocity
growth hormone
clinical trial
GB08 injection
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Sequential
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPhaseII GB08 0.4 mg/kg GB08 0.4mg/kg subcutaneous injection, once a week for 24 weeks | 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. |
ExperimentalPhaseII GB08 0.8 mg/kg GB08 0.8mg/kg subcutaneous injection, once a week for 24 weeks | 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. |
ExperimentalPhaseII GB08 1.2 mg/kg GB08 1.2mg/kg subcutaneous injection, once a week for 24 weeks | 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. |
Active ComparatorPhaseII Norditropin NordiFlex Norditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 24 weeks | Norditropin NordiFlex Norditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 24 weeks (Phase II) or 52 weeks (Phase III) |
ExperimentalPhaseIII GB08 GB08 subcutaneous injection (The dose will be determined by data from PhaseII), once a week for 52 weeks | 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. |
Active ComparatorPhaseIII Norditropin NordiFlex Norditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 52 weeks | Norditropin NordiFlex Norditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 24 weeks (Phase II) or 52 weeks (Phase III) |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
PhaseII-Comparison of annualized height velocity at 24 weeks | Comparison of annualized height velocity of PGHD patients receiving 24-week GB08 and Norditropin NordiFlex treatment | From enrollment to end of treatment at 24 weeks |
PhaseIII-Comparison of annualized height velocity at week 52 | Comparison of annualized height velocity between PGHD patients receiving GB08 and Norditropin NordiFlex at 52 weeks | From enrollment to end of treatment at week 52 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
PhaseII-annualized height velocity at weeks 4, 12, 36, 48, 52 | From enrollment to weeks 4, 12, 36, 48, 52 | |
PhaseII-Standard deviation (SD) scores of AHV of GB08 injection and Norditropin NordiFlex at baseline, and at weeks 4, 12, 36, 48, 52 | From enrollment to weeks 4, 12, 36, 48, 52 | |
PhaseII-Standard deviation of actual height SDS (Ht SDS CA) of GB08 injection and Norditropin NordiFlex at weeks 4, 12, 24, 36, 48, 52 | From enrollment to weeks 4, 12, 24, 36, 48, 52 | |
PhaseII-Standard deviation of bone age (BA) SDS (Ht SDS BA) of GB08 injection and Norditropin NordiFlex at week 24 and 52 | From enrollment to weeks 24 and 52 | |
PhaseII-Tanner stage changes at baseline and at weeks 12, 24, 52 | From enrollment to weeks 12, 24, and 52 | |
PhaseII-Body weight and BMI changes at baseline and at weeks 2, 4, 8, 12, 24, 52 | From enrollment to weeks 2, 4, 8, 12, 24, and 52 | |
PhaseII-Ratio of BA to CA at baseline and at weeks 24, 52 | From enrollment to weeks 24 and 52 | |
PhaseII-Serum IGF-1, IGF-1 SDS, and IGFBP-3 levels, and their changes from baseline at weeks 2, 4, 8, 12, 24, 36, 48, 52 | From enrollment to weeks 2, 4, 8, 12, 24, 36, 48, and 52 | |
PhaseII-Serum IGF-1, IGF-1 SDS, and IGFBP-3 levels, and their changes from baseline at 48 hours post-dose of GB08 injection at weeks 2, 4, 8, 12, 24, 36, 48, 52 | From enrollment to weeks 2, 4, 8, 12, 24, 36, 48, and 52 | |
PhaseIII-AHV of GB08 injection and Norditropin NordiFlex at baseline, and at weeks 4, 12, 24, 36, 48, 52 | From enrollment to weeks 4, 12, 24, 36, 48, and 52 | |
PhaseIII-Standard deviation (SD) scores of AHV of GB08 injection and Norditropin NordiFlex at baseline, and at weeks 4, 12, 24, 36, 48, 52 | From enrollment to weeks 4, 12, 24, 36, 48, and 52 | |
PhaseIII-Standard deviation of actual height SDS (Ht SDS CA) of GB08 injection and Norditropin NordiFlex at weeks 4, 12, 24, 36, 48, 52 | From enrollment to weeks 4, 12, 24, 36, 48, and 52 | |
PhaseIII-Standard deviation of bone age (BA) SDS (Ht SDS BA) of GB08 injection and Norditropin NordiFlex at week 52 | From enrollment to week 52 | |
PhaseIII-Tanner stage changes at baseline and at weeks 12, 24, 52 | From enrollment to weeks 12, 24, and 52 | |
PhaseIII-Body weight and BMI changes at baseline and at weeks 2, 4, 8, 12, 24, 52 | From enrollment to weeks 2, 4, 8, 12, 24, and 52 | |
PhaseIII-Serum IGF-1, IGF-1 SDS, and IGFBP-3 levels, and their changes from baseline at weeks 2, 4, 8, 12, 24, 36, 48, 52 | From enrollment to weeks 2, 4, 8, 12, 24, 36, 48, and 52 | |
PhaseIII-Serum IGF-1, IGF-1 SDS, and IGFBP-3 levels, and their changes from baseline at 48 hours post-dose of GB08 injection at weeks 2, 4, 8, 12, 24, 36, 48, 52 | From enrollment to weeks 2, 4, 8, 12, 24, 36, 48, and 52 | |
PhaseII-Safety Evaluation Endpoints | Adverse events (AEs), vital signs, ECG, physical examination, abnormal clinical laboratory parameters (including but not limited to complete blood count, blood biochemistry, urinalysis, thyroid function, fasting insulin, prolactin, HbA1c, fasting serum cortisol), and injection site examination. | weeks 2, 4, 8, 12, 24, 36, 48, 52. |
PhaseII-Immunogenicity Evaluation Endpoints | Blood samples will be collected at baseline and at weeks 12, 24, 36, 52 to determine the presence of anti-drug antibodies (ADA). If ADA is positive, neutralizing antibody and titer analysis will be performed. If ADA-positive subjects are needed for safety and efficacy analysis, additional ADA, neutralizing antibody, and titer testing may be conducted. | weeks 12, 24, 36, 52 |
PhaseII-Pharmacokinetics Evaluation Endpoints | PK parameters: maximum concentration (Cmax), area under the curve from time 0 to the last measurable concentration (AUC0-t), area under the curve from time 0 to infinity (AUC0-inf), time to peak concentration (Tmax), elimination rate constant (λz), elimination half-life (t1/2), apparent volume of distribution (Vd/F), apparent clearance (CL/F), AUC0-inf extrapolated percentage (AUC\_%Extrap). | weeks 2, 4, 8, 12, 24, 36, 48, 52. |
PhaseII-Pharmacodynamics Evaluation Endpoints | Observed maximum effect (Emax), time to reach maximum effect (TEmax), area under the effect-time curve from time 0 to the last measurable time point (AUEC0-t), area under the effect-time curve from time 0 to 24 hours (AUEC0-24h), area under the effect-time curve from time 0 to 168 hours (AUEC0-168h). | time 0 to 168 hours |
PhaseIII-Safety Evaluation Endpoints | Adverse events (AEs), vital signs, 12-lead ECG, physical examination, abnormal clinical laboratory parameters (including but not limited to complete blood count, blood biochemistry, urinalysis, thyroid function, fasting insulin, prolactin, HbA1c, fasting serum cortisol), and injection site examination. | weeks 2, 4, 8, 12, 24, 36, 48, 52 |
PhaseIII-Immunogenicity Evaluation Endpoints | Blood samples will be collected at baseline and at weeks 12, 24, 36, 52 to determine the presence of anti-drug antibodies (ADA). If ADA is positive, neutralizing antibody and titer analysis will be performed. If ADA-positive subjects are needed for safety and efficacy analysis, additional ADA, neutralizing antibody, and titer testing may be conducted. | weeks 12, 24, 36, 52 |
PhaseIII-Pharmacodynamics Evaluation Endpoints | GB08 injection and Norditropin NordiFlex concentrations of IGF-1 and IGFBP-3, relative changes from baseline, and percentage changes at baseline and at weeks 12, 24, 36, 52. | weeks 12, 24, 36, 52 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
3 Years
Eligible Sexes
All
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:
- 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.
- Annualized height velocity (AHV) ≤ 5.0 cm/year, calculated from measurement of 6 to 18 months before screening.
- GH peak ≤ 10 ng/ml proved by two different GH stimulation tests within a year before screening.
- 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.
- History of systematic growth-promoting therapy, including growth hormone and sex hormones.
- Severe allergic constitution or known allergy to growth hormone or its excipients, such as mannitol, lysine, or sodium chloride.
- Closed epiphyses.
- Other types of growth disorders such as idiopathic short stature, Turner syndrome, Noonan syndrome, Prader-Willi syndrome, and Russell-Silver syndrome.
- 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.
- 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.
- 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).
- Use of corticosteroids or other steroids within the past 12 months, such as long-term steroid use for asthma.
- History of pituitary or hypothalamic tumors, or other intracranial tumors on MRI; history of leukemia, lymphoma, or other malignancies.
- History of radiation therapy or chemotherapy.
- Congenital intracranial hypertension.
- Femoral head slipped epiphysis (SCFE).
- Spinal scoliosis > 15°.
- Participation in any other drug clinical trial within the past 3 months (as a subject).
- Other factors deemed unsuitable for participation in the study by the investigator.
Shenzhen Kexing Pharmaceutical Co., Ltd.Study Central Contact
Contact: Yanqing Lin, 86-0755-23018589, [email protected]
Contact: Jinhai Lin, 86-13760806104, [email protected]
16 Study Locations in 1 Countries
Fujian
Xiamen Maternal and Child Health Hospital, Xiamen, Fujian, 361000, China
Xiaoqing Yang, Sub-Investigator
Henan
Nanyang Central Hospital, Nanyang, Henan, 473000, China
Na Xu, Sub-Investigator
The First Affiliated Hospital of Nanyang Medical College, Nanyang, Henan, 473000, China
Xiaoxia Shi, Sub-Investigator
The Third Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, 453003, China
Jinfen Han, Sub-Investigator
Hubei
Wuhan Children's Hospital, Wuhan, Hubei, 430016, China
Hui Yao, Sub-Investigator
Jiangsu
Suzhou University Children's Hospital, Suzhou, Jiangsu, 215000, China
Rongrong Xie, Sub-Investigator
Jiangxi
Jiangxi Children's Hospital, Nanchang, Jiangxi, 330006, China
Yu Yang, Sub-Investigator
Pingxiang Maternal and Child Health Hospital, Pingxiang, Jiangxi, 337000, China
Li Zhou, Sub-Investigator
Jilin
The First Hospital of Jilin University, Changchun, Jilin, 130021, China
Yining Zhang, Sub-Investigator
Shandong
Linyi Maternal and Child Health Hospital, Linyi, Shandong, 276000, China
Xiuying Ge, Sub-Investigator
Sichuan
Chengdu Women's and Children's Central Hospital, Chengdu, Sichuan, 610017, China
Fang Tang, Sub-Investigator
Meishan People's Hospital, Meishan, Sichuan, 620010, China
Yangfan Fei, Sub-Investigator
The Second People's Hospital of Yibin, Yibin, Sichuan, 644000, China
Lan Yao, Sub-Investigator
Zhejiang
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, China
Qin Zhou, Sub-Investigator
Children's Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310051, China
Junfen Fu, Principal Investigator
Ningbo Women's and Children's Hospital, Ningbo, Zhejiang, 315010, China
Shuxia Ding, Sub-Investigator