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Tests treatment safety and results for Small for Gestational Age
Official title The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age
ClinicalTrials.gov ID: NCT07309562
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 small for gestational age.
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, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection，once a week，compared with recombinant human growth hormone (rhGH) in children with short stature born small for gestational age (SGA).It plans to enroll 141 children with short stature born small for gestational age (SGA), who will be stratified by gender and age and randomized in a 1:1:1 ratio to either Experimental Group 1, Experimental Group 2, or the Active Control Group. All participants will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks).
- 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 11
You may be able to join if
- Prepubertal (Tanner stage I) children: boys aged ≥2 and \<11 years, and girls aged ≥2 and \<10 years at screening.
- Bone age is not more than 1 year advanced or more than 2 years delayed compared to chronological age (i.e., -2 years ≤ bone age - chronological age ≤...
- Birth weight and/or length below the 10th percentile for gestational age and sex, according to the reference values in Appendix 1.
- Gestational age at birth ≥28 weeks.
- Height at screening below -2 SD for age and sex, according to the reference values in Appendix 2.
You likely can't join if
- people with closed epiphyses.
- people with other types of growth abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome...
- Participation in any other clinical trial with drug or non-drug interventions within 3 months prior to screening.
- Use of inhaled corticosteroids for more than 2 consecutive weeks, or oral/intravenous corticosteroids for more than 1 consecutive week, within 3...
- Current or long-term requirement for therapies that may affect growth, including but not limited to methylphenidate, sex hormones...
- Abnormal liver or kidney function at screening (ALT \> 1.5 times the upper limit of normal [ULN], Cr \> ULN).
See the full eligibility criteria
- Prepubertal (Tanner stage I) children: boys aged ≥2 and \<11 years, and girls aged ≥2 and \<10 years at screening.
- Bone age is not more than 1 year advanced or more than 2 years delayed compared to chronological age (i.e., -2 years ≤ bone age - chronological age ≤ 1 year).
- Birth weight and/or length below the 10th percentile for gestational age and sex, according to the reference values in Appendix 1.
- Gestational age at birth ≥28 weeks.
- Height at screening below -2 SD for age and sex, according to the reference values in Appendix 2.
- Body mass index (BMI) between the 5th and 95th percentiles for age and sex, according to the reference values in Appendix 3.
- Peak GH level ≥10.0 ng/mL in at least one prior GH stimulation test.
- No prior systemic growth-promoting therapy (used continuously for ≥1 month), including but not limited to growth hormone, insulin-like growth factor-1 (IGF-1), etc.
- Legal guardian has provided written informed consent. If the participant is ≥8 years old, they must also provide written assent. For participants under 8 years old who are capable of expressing agreement, their assent...
- people with closed epiphyses.
- people with other types of growth abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, short stature...
- Participation in any other clinical trial with drug or non-drug interventions within 3 months prior to screening.
- Use of inhaled corticosteroids for more than 2 consecutive weeks, or oral/intravenous corticosteroids for more than 1 consecutive week, within 3 months prior to screening.
- Current or long-term requirement for therapies that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, or...
- Abnormal liver or kidney function at screening (ALT \> 1.5 times the upper limit of normal [ULN], Cr \> ULN).
- Diagnosis of diabetes mellitus, or two consecutive fasting blood glucose measurements ≥ 6.1 mmol/L prior to randomization.
- Chronic infectious diseases which, in the investigator's judgment, may affect study participation (e.g., chronic hepatitis B).
- Systemic chronic diseases, such as chronic kidney disease, severe cardiovascular diseases, or psychiatric/psychological disorders.
- Congenital skeletal dysplasia, scoliosis exceeding 15°, limping gait, or a prior diagnosis of slipped capital femoral epiphysis.
- History of intracranial hypertension.
- Past or current history of malignant tumors, including intracranial tumors.
- Known allergy to growth hormone or any of its excipients.
- Any other condition deemed by the investigator as inappropriate for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changchun, China
- Changsha, China
- Chengdu, China
- Chongqing, China
- Fuzhou, China
- Guangzhou, China
- Haikou, China
- Hangzhou, China
- Harbin, China
- Hefei, China
- Hohhot, China
- Jinan, China
- Jining, China
- Jiujiang, China
- Kunming, China
- Lanzhou, China
- Liuzhou, China
- Luoyang, China
- Nanchang, China
+ 17 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 all sexes, 2 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Changchun, China; Changsha, China; Chengdu, China; Chongqing, China; Fuzhou, China and 31 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.