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DwarfismPhase 2NCT03221088

A Study of PEG-somatropin in the Treatment of Children With Idiopathic Short Stature

A Phase 2 study testing Jintrolong® low dose group and Jintrolong® high dose group in people with Dwarfism, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to explore the optimal dose of pegylated recombinant human growth hormone (PEG-rhGH) injection to treat children with idiopathic short stature (ISS), evaluate its safety and efficacy, and provide scientific and reliable evidence for the medication dosage in Phase III clinical study. Read more about this study

Who is it for?
Ages 4 to 9 years
Conditions the study is for
Dwarfism
What is being tested?
Jintrolong® low dose group and Jintrolong® high dose group
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
7 sitesChina
Study dates
Jun 2015to Dec 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Boys are between 4 and 9 years of age and girls are between 4 and 8 years of age.
  • Height <-2 SD for chronological age.
  • Growth velocity<5.0 cm/yr.
  • GH peak concentration ≥10.0 ng/mL in two different stimulation tests.
  • The difference of bone age (BA) and chronological age (CA) is within -2 to +2.
  • IGF-1 concentration is between -2 SDS to +2 SDS.
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  • Prepubertal Status(Tanner Stage I).
  • Birth weight within the normal range.
  • Growth hormone treatment-naive.
  • Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.

Who cannot join

  • Subjects with abnormal liver and kidney functions (ALT > upper limit of normal value; Cr > upper limit of normal value).
  • Subjects are positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests.
  • Subjects with known highly allergic constitution or allergy to investigational product or its excipient.
  • Subjects with systemic chronic disease and immune deficiency.
  • Patients diagnosed with tumor.
  • Patients with mental disease.
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  • Patients with other types of abnormal growth and development.
  • Growth hormone deficiency (GHD) (confirmed by GH stimulation test);
  • Turner syndrome (confirmed by karyotype test of girls);
  • Noonan syndrome (hypertelorism, pectus carinatum, hypophrenia, frequently with skin disease and congenital heart disease, missense mutation of the protein tyrosine phosphatase, non-receptor type 11 (PTPN11) gene on chromosome 12 for half of the patients, for both male and female patients);
  • Laron sydrome (confirmed by IGF-1 generation test);
  • Small for gestational age ( the birth height or weight is below the tenth percentile or 2 SD, with catch-up growth uncompleted at 2 years old).
  • Growth disorders caused by malnutrition or hypothyroidism (thyroid function test).
  • Congenital skeletal abnormalities or scoliosis, claudication.
  • Subjects with impaired glucose regulation (IGR) (including impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) ) or diabetes).
  • Subjects with abnormal electrolyte, blood gas analysis (vein), creatine kinase.
  • Subjects who took part in other clinical trials within 3 months.
  • Subjects who received medications which may interfere GH secretion or GH function, or other hormones within 3 months (such as sex steroids, glucocorticoids, etc.).
  • For patients with potential high tumor risks such as tumor markers exceed normal range and some other relative information, they may be excluded from the treatment.
  • Other conditions which is inappropriate for this study in the opinion of the investigator.

Trial locations and contacts

7 sites in 1 country.

Yanlin Chen contact

+86-60871786-8197

chenyanlin@gensci-china.com

7 sites in 1 country

China7 sites, 7 recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin

    Hongwei Du, MD

    Recruiting

  • The Children's Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Junfen Fu, MD

    Recruiting

  • The First Affiated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

    Yuhua Hu, MD

    Recruiting

  • Shanghai Children's Hospital of Fudan University

    Shanghai

    Feihong Luo, MD

    Recruiting

  • Shanghai Children's Hospital

    Shanghai

    Pin Li, MD

    Recruiting

  • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

    Xiaoping Luo, PhD

    Recruiting

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu

    Zhuangjian Xu, MD

    Recruiting

Other trials in China

About this study

Official title: Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Idiopathic Short Stature: A Controlled, Prospective, Randomized, Multicenter Phase-II Study With An Untreated Control Group.

This study aims to explore the optimal dose of pegylated recombinant human growth hormone (PEG-rhGH) injection to treat children with idiopathic short stature (ISS), evaluate its safety and efficacy, and provide scientific and reliable evidence for the medication dosage in Phase III clinical study.

Conditions
Dwarfism
Being tested
Jintrolong® low dose group, Jintrolong® high dose group
Medical subject headings
Dwarfism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Jintrolong® low dose groupDrug

    Also called PEG-somatropin

    PEG-somatropin 0.1mg/kg/wk by weekly subcutaneous injection for 52 weeks.

  • Jintrolong® high dose groupDrug

    Also called PEG-somatropin

    PEG-somatropin 0.2 mg/kg/wk by weekly subcutaneous injection for 52 weeks.

Study groups in NCT03221088
Study groupRoleWhat they receive
Jintrolong® low dose groupExperimentalPEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.1 mg/kg/w by subcutaneous injection for 52 weeks.
Receives: Drug: Jintrolong® low dose group; Drug: Jintrolong® high dose group
Jintrolong® high dose groupExperimentalPEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.2 mg/kg/w by subcutaneous injection for 52 weeks.
Receives: Drug: Jintrolong® low dose group; Drug: Jintrolong® high dose group
Negative control groupNo interventionUntreated Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Height Standard Deviation Score for Chronological Age (ΔHtSDSCA)

    Change in Height Standard Deviation Score for Chronological Age (ΔHtSDSCA) from Baseline to 52 weeks；ΔHtSDSCA=(height Yx - reference mean for CA Yx) / reference SD for CA Yx (Yx refers to the height value at particular timepoint x)

    Measured: Baseline，52 weeks

Secondary outcomes (4)

  1. Change in Annualized Height Velocity

    Annualized Height Velocity=12×(Height Yx - Height at Baseline)/(Date of Yx - Date of Baseline) (Yx refers to the height value at particular timepoint x)

    Measured: Baseline，52 weeks

  2. Change in Bone Maturation

    Bone Maturation=(BA Yx-BA at Baseline)/(Date of Yx - Date of Baseline) (Yx refers to the BA value at particular timepoint x)

    Measured: Baseline，52 weeks

  3. Change in IGF-1 Standard Deviation Score (IGF-1 SDS)

    GF-1 SDS=(IGF-1 Yx - reference mean for CA Yx) / reference SD for CA Yx (Yx refers to the IGF-1 value at particular timepoint x)

    Measured: Baseline，52 weeks

  4. IGF-1/IGFBP-3 molar ratio at 52 weeks

    IGF-1/IGFBP-3 molar ration=[IGF-1(ng/ml)/7.6]/[IGFBP-3 (ng/ml)/25.75]

    Measured: Baseline，52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2017
  2. Study startJun 2015
  3. Primary completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03221088
Sponsor's protocol ID
GenSci 033 CT-one year
Status last verified
Jul 2017
First submitted
14 Jul 2017
Last updated
19 Jul 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Jintrolong® low dose group and Jintrolong® high dose group in people with Dwarfism, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yanlin Chen (+86-60871786-8197, chenyanlin@gensci-china.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Height Standard Deviation Score for Chronological Age (ΔHtSDSCA) (time frame: Baseline，52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03221088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.

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