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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3+
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PEG-rhGH Injection

    Drug

    Jintrolong® Dose 1, subcutaneous injection, once weekly for 26 weeks for 24 subjects.. Jintrolong® Dose 2, subcutaneous injection, once weekly for 26 weeks for 24 subjects..

  • hGH Injection

    Drug

    Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks (active comparator) for 24 subjects.

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: PEG-rhGH dose 1 weeklyExperimental treatment 1 intervention
Group B: PEG-rhGH dose 2 weeklyExperimental treatment 1 intervention
Group C: Daily hGH (active control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Annual height velocity at Week 26 of treatment

Time frame
26 Weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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