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Tests treatment safety and results for Turner Syndrome
Official title The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature
ClinicalTrials.gov ID: NCT07614152
What this study is testing
What is Inpegsomatropin-Injection?
Inpegsomatropin-Injection is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for turner syndrome.
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 is a multicenter, randomized, open-label, positive-controlled phase III confirmatory clinical study. A total of 84 children with short stature due to Turner Syndrome (TS) are planned to be enrolled.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 12, women only
You may be able to join if
- Prepubertal girls at Tanner stage I, with age ≥ 2 years and \< 12 years at the time of informed consent signature.
- With clinical manifestations of Turner syndrome and a confirmed diagnosis of Turner syndrome based on peripheral blood karyotype analysis (karyotype...
- At screening, bone age is delayed relative to chronological age or advanced by no more than 1 year (i.e., bone age - chronological age ≤ 1 year).
- At screening, height is below -2 standard deviations (-2SD) of the mean for age and gender; height reference is shown in Appendix 1.
- No prior systematic pharmacological growth-promoting treatment (continuous use for ≥ 1 month), including but not limited to growth hormone...
You likely can't join if
- people with closed epiphyses.
- Patients with Turner syndrome carrying Y chromosome or Y-chromosome-derived fragments and without gonadectomy.
- Other types of growth and development abnormalities, including but not limited to growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi...
- Participation in any other clinical trial within 3 months prior to screening with pharmacological or non-pharmacological intervention received.
- Inhaled glucocorticoids used continuously for more than 2 weeks, or oral/intravenous glucocorticoids used continuously for more than 1 week within 3...
- Receiving other treatments that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone...
See the full eligibility criteria
- Prepubertal girls at Tanner stage I, with age ≥ 2 years and \< 12 years at the time of informed consent signature.
- With clinical manifestations of Turner syndrome and a confirmed diagnosis of Turner syndrome based on peripheral blood karyotype analysis (karyotype analysis of at least 30 metaphase cells).
- At screening, bone age is delayed relative to chronological age or advanced by no more than 1 year (i.e., bone age - chronological age ≤ 1 year).
- At screening, height is below -2 standard deviations (-2SD) of the mean for age and gender; height reference is shown in Appendix 1.
- No prior systematic pharmacological growth-promoting treatment (continuous use for ≥ 1 month), including but not limited to growth hormone, insulin-like growth factor 1 (IGF-1), etc.
- Thyroid hormone replacement therapy (if applicable) received prior to randomization should be maintained on a stable regimen for at least 4 weeks.
- The legal guardian understands and signs the informed consent form; participants aged ≥ 8 years shall also sign the informed consent form. For participants aged under 8 years who are capable of expressing assent, their...
- people with closed epiphyses.
- Patients with Turner syndrome carrying Y chromosome or Y-chromosome-derived fragments and without gonadectomy.
- Other types of growth and development abnormalities, including but not limited to growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, and growth retardation caused by malnutrition.
- Participation in any other clinical trial within 3 months prior to screening with pharmacological or non-pharmacological intervention received.
- Inhaled glucocorticoids used continuously for more than 2 weeks, or oral/intravenous glucocorticoids used continuously for more than 1 week within 3 months prior to screening.
- Receiving other treatments that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, etc.
- Abnormal liver and renal function at screening (ALT \> 2 times the upper limit of normal; Cr \> upper limit of normal).
- people with abnormal glucose metabolism, including: a. Diagnosed diabetes mellitus; b. Fasting blood glucose ≥ 6.1 mmol/L on two consecutive measurements; c. Glycated hemoglobin (HbA1c) ≥ 6.5%; d. Impaired glucose...
- Presence of chronic infectious diseases judged by the investigator to interfere with study participation, such as chronic hepatitis B.
- people with systemic chronic diseases, such as chronic kidney disease, severe cardiovascular diseases (e.g., aortic dissection, uncontrolled hypertension), psychiatric and psychological disorders.
- people with severe congenital skeletal dysplasia; or those with scoliosis \> 20°, significant kyphosis, claudication, or a prior diagnosis of slipped capital femoral epiphysis.
- people with a prior history of intracranial hypertension.
- people with a history of malignant tumor or current active malignant tumor, including intracranial tumors.
- Known hypersensitivity to growth hormone or its excipients.
- people with celiac disease who have not maintained a gluten-free diet within 12 months prior to screening.
- Any other conditions deemed inappropriate for enrollment in this clinical trial by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Anyang, China
- Beijing, China
- Changsha, China
- Chengdu, China
- Chongqing, China
- Dalian, China
- Guangzhou, China
- Hangzhou, China
- Hebei, China
- Henan, China
- Huzhou, China
- Jiangxi, China
- Jilin City, China
- Jinan, China
- Jining, China
- Kunming, China
- Lanzhou, China
- Nanning, China
- Pingxiang, China
- Qilu, China
+ 19 more site(s).
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 female, 2 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anyang, China; Beijing, China; Changsha, China; Chengdu, China; Chongqing, China; Dalian, China and 33 more location(s). 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.