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Tests treatment safety and results for Short Stature Children Born Small for Gestational Age...
Official title A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics
ClinicalTrials.gov ID: NCT07260500
What this study is testing
What is PEG-rhGH Injection?
PEG-rhGH Injection is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for short stature children born small for gestational age (sga).
Also referred to as Jintrolong®.
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 will take place at multiple sites and is divided into three phases:an initial 4-week getting-to-know-you phase,a 26-week main phase where participants receive medication,and a 4-week follow-up phase.Participants will be divided into three groups:two will receive different doses of PEG-rhGH Injection,and the third will receive hGH Injection.The goal is to determine which medication works best.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 and older
You may be able to join if
- Born full-term and "small-for-dates" - Born at 37-41 weeks (full-term). - Birth weight below the 10th percentile for that week of pregnancy and sex .
- At least 3 years old on the day the parent signs the consent form.
- Still prepubertal (Tanner stage I - no signs of puberty yet).
- Height at the first study visit is more than 2 standard deviations below the average for his or her age and sex.
- Bone age on X-ray is no more than 1 year ahead of real age.
You likely can't join if
- Severe allergy to growth hormone or its ingredients.
- Growth-hormone deficiency.
- Any chromosome/genetic/syndrome cause of short stature.
- Other diseases that can impair growth.
- Cognitive, developmental, or psychiatric disorders that could affect assessments .
- Current or past cancer, or high familial cancer risk.
See the full eligibility criteria
- Born full-term and "small-for-dates" - Born at 37-41 weeks (full-term). - Birth weight below the 10th percentile for that week of pregnancy and sex .
- At least 3 years old on the day the parent signs the consent form.
- Still prepubertal (Tanner stage I - no signs of puberty yet).
- Height at the first study visit is more than 2 standard deviations below the average for his or her age and sex.
- Bone age on X-ray is no more than 1 year ahead of real age.
- Never taken growth hormone, IGF-1, or any ghrelin-like medicine before.
- Both the subject and their guardian are able to voluntarily sign the Informed Consent Form (ICF) and voluntarily cooperate in completing the trial according to the protocol. If the subject is legally incompetent...
- Severe allergy to growth hormone or its ingredients.
- Growth-hormone deficiency.
- Any chromosome/genetic/syndrome cause of short stature.
- Other diseases that can impair growth.
- Cognitive, developmental, or psychiatric disorders that could affect assessments .
- Current or past cancer, or high familial cancer risk.
- Positive hepatitis B, hepatitis C, HIV, or active tuberculosis at screening.
- Abnormal liver or kidney blood tests.
- Pre-diabetes or diabetes at screening .
- Systemic steroids \> 28 consecutive days or \> 14 days total in the last 3 months.
- High-dose inhaled steroids \> 28 days in the last year.
- Prior use of aromatase inhibitors, GnRH analogues, sex hormones, anabolic agents, or other drugs that affect growth. 13. Unable to receive subcutaneous injections.
- Claustrophobia or inability to undergo brain MRI.
- Participated in another clinical trial with investigational treatment within 3 months.
- Any other condition that, in the investigator's opinion, makes the child unsuitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, 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.