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New treatment option for Growth Hormone Deficiency (GHD)
Official title GB06 Phase III Trial for Pediatric Growth Hormone Deficiency
ClinicalTrials.gov ID: NCT07553351
What this study is testing
What is GB06?
GB06 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for growth hormone deficiency (ghd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate the efficacy and safety of GB06 (a biosimilar of Norditropin®FlexProTM from Novo Nordisk) for the treatment of growth disorders caused by growth hormone deficiency (GHD) in children. It aims to determine whether the annual height velocity (an index of height growth rate) in children diagnosed with GHD after 52 weeks of GB06 intervention is comparable to that of Norditropin®FlexProTM.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 11
You may be able to join if
- The legal guardian of the participant understands and signs the written informed consent form (ICF); Participants over 8 years old are also required...
- Age ≥ 3 years old and ≤ 11 years old (boys) or ≤ 10 years old (girls);
- Height below two standard deviations (SD) of the average height of children of the same age and gender;
- Annual height velocity (AHV) \<5cm/year, based on height within 6 months to 18 months before screening;
- Body mass index (BMI) within the average ±2 SD of healthy children of the same age and gender;
You likely can't join if
- Known allergy to ingredients of the study drug;
- Previous treatment with recombinant human growth hormone (rhGH) or IGF-1 or combination with other treatments that may affect growth;
- Administration of any investigational drug within 3 months before screening or participation in another clinical trial before randomization;
- Small for gestational age;
- Epiphyseal closure;
- Congenital intracranial hypertension;
See the full eligibility criteria
- The legal guardian of the participant understands and signs the written informed consent form (ICF); Participants over 8 years old are also required to sign the ICF, and if they are under 8 years old but can express...
- Age ≥ 3 years old and ≤ 11 years old (boys) or ≤ 10 years old (girls);
- Height below two standard deviations (SD) of the average height of children of the same age and gender;
- Annual height velocity (AHV) \<5cm/year, based on height within 6 months to 18 months before screening;
- Body mass index (BMI) within the average ±2 SD of healthy children of the same age and gender;
- Short stature with normal intellectual development;
- Tanner stage I (testicular volume \<4ml for boys, no palpable breast gland tissue for girls);
- IGF-1 level below the reference value corresponding to -1SDS for children of the same age and gender;
- Bone age lags behind the chronological age;
- Diagnosis as GHD by GH stimulation test with two different drugs within 12 months before screening, and the peak GH level ≤ 10.0ng/ml;
- A standard karyotype of 46, XX for girls.
- Known allergy to ingredients of the study drug;
- Previous treatment with recombinant human growth hormone (rhGH) or IGF-1 or combination with other treatments that may affect growth;
- Administration of any investigational drug within 3 months before screening or participation in another clinical trial before randomization;
- Small for gestational age;
- Epiphyseal closure;
- Congenital intracranial hypertension;
- Slipped capital femoral epiphysis;
- GHD secondary to another pituitary hormone deficiency;
- Previous history or current diagnosis of malignancy (including intracranial tumors); Intracranial tumors must be confirmed by magnetic resonance imaging or computed tomography;
- History of fundus lesions (optic nerve papilledema lesions);
- Diagnosis of diabetes, or fasting blood glucose ≥ 7.0 mmol/L or hemoglobin A1c (HbA1c) ≥ 6.5%;
- Administration of systemic corticosteroid therapy consecutively for more than 2 weeks within 3 months before screening;
- Expected requirement to inhale budesonide \>400μg/day or equivalent dose of inhaled glucocorticoid therapy for more than four consecutive weeks during the trial;
- Other growth abnormalities or abnormalities that may affect height, including but not limited to: chromosomal aneuploidy, Turner syndrome, Lehren's syndrome, Noonan syndrome, Prader-Willi syndrome, SHOX-1 gene...
- Other clinically significant abnormalities that may affect growth or assessment of growth capacity, including but not limited to hepatic and renal dysfunction [e.g., alanine aminotransferase (ALT)\> 1.5 times the upper...
- Infectious diseases, such as hepatitis B, hepatitis C, AIDS, syphilis, and tuberculosis. Hepatitis B virus DNA levels will be assessed in individuals who are positive for HBV surface antigen. A hepatitis C virus RNA...
- Concomitant use of other treatments that may affect growth, including but not limited to methylphenidate for attention deficit hyperactivity disorder;
- History of drug or alcohol abuse;
- Children with hypothyroidism and/or adrenal insufficiency who have not received adequate stable replacement therapy lasting at least 90 days before randomization;
- Other diseases that the investigator believes may endanger the safety of the participant or protocol compliance;
- Potentially poor compliance in this study.
- Other conditions that the investigator deems unsuitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.