A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics

GeneScience Pharmaceuticals (GenSci)

Status and phase: Enrolling; Phase 2

Conditions: Short Stature Children Born Small for Gestational Age (SGA)

Treatments: Drug: PEG-rhGH Injection; Drug: hGH Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07260500

GenSci031-202

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion 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.
• Child and parent/guardian are willing to sign the consent form and follow the study visits.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

PEG-rhGH dose 1 weekly

Experimental group

Description:

Jintrolong® dose 1, subcutaneous injection, once every week for 26 weeks.

Treatment:

Drug: PEG-rhGH Injection

PEG-rhGH dose 2 weekly

Experimental group

Description:

Jintrolong® dose 2, subcutaneous injection, once every week for 26 weeks

Treatment:

Drug: PEG-rhGH Injection

Daily hGH (active control)

Active Comparator group

Description:

Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks.

Treatment:

Drug: hGH Injection