NCT03221088

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

3.5 years

First QC Date

July 14, 2017

Last Update Submit

July 17, 2017

Conditions

Dwarfism

Outcome Measures

Primary Outcomes (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)

    Baseline，52 weeks

Secondary Outcomes (4)

  • Change in Annualized Height Velocity

    Baseline，52 weeks

  • Change in Bone Maturation

    Baseline，52 weeks

  • Change in IGF-1 Standard Deviation Score (IGF-1 SDS)

    Baseline，52 weeks

  • IGF-1/IGFBP-3 molar ratio at 52 weeks

    Baseline，52 weeks

Study Arms (3)

Jintrolong® low dose group

EXPERIMENTAL

PEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.1 mg/kg/w by subcutaneous injection for 52 weeks.

Drug: Jintrolong® low dose groupDrug: Jintrolong® high dose group

Jintrolong® high dose group

EXPERIMENTAL

PEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.2 mg/kg/w by subcutaneous injection for 52 weeks.

Drug: Jintrolong® low dose groupDrug: Jintrolong® high dose group

Negative control group

NO INTERVENTION

Untreated Control Group

Interventions

Jintrolong® low dose groupDRUG

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

Also known as: PEG-somatropin
Jintrolong® high dose groupJintrolong® low dose group
Jintrolong® high dose groupDRUG

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

Also known as: PEG-somatropin
Jintrolong® high dose groupJintrolong® low dose group

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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).
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

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

Wuhan, Hubei, China

RECRUITING

The First Affiated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Shanghai Children's Hospital of Fudan University

Shanghai, China

RECRUITING

Shanghai Children's Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Dwarfism

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Xiaoping Luo

    Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanlin Chen

CONTACT

+86-60871786-8197chenyanlin@gensci-china.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 18, 2017

Study Start

June 1, 2015

Primary Completion

December 1, 2018

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

CN(7)