NCT03635580

Brief Summary

Phase 1: To evaluate the safety and efficacy of 0.05mg/kg/d of rhGH (Jintropin®) in the treatment of children with idiopathic short stature (ISS) in 52 weeks. Phase 2: To evaluate the safety and efficacy of rhGH (Jintropin®) in the treatment of children with ISS in 2 years

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2018

Typical duration for phase_3

Geographic Reach
1 country

9 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 11, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

3.3 years

First QC Date

August 15, 2018

Last Update Submit

August 15, 2018

Conditions

Dwarfism

Outcome Measures

Primary Outcomes (1)

  • ΔHtSDSca (The change of height standard deviation score of chronological age before and after treatment)

    ΔHtSDSca was the difference of HtSDSca before and after treatment, and HtSDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age.

    Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.

Secondary Outcomes (4)

  • ΔHT (Change of height)

    Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.

  • △BA/CA (bone age change / chronological age)

    Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.

  • Yearly growth velocity

    Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.

  • ΔIGF-1 SDS (Change of insulin-like growth factor 1 standard deviation score)

    Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.

Study Arms (1)

rhGH/Jintropin AQ

EXPERIMENTAL

Jintropin AQ, injection, 30IU/10mg/3ml/cartridge, 0.05mg /kg/d in phase 1 and 0.05-0.07mg/kg/d in phase 2.

Other: Negative control

Interventions

Negative controlOTHER

Untreated-control group

rhGH/Jintropin AQ

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Boys are between 4 and 10 years old age and girls are between 4 and 9 years old age;
  • Height \<-2.25 SD (Standard deviation) for chronological age;
  • GH (Growth hormone) peak concentration ≥10.0 ng/mL in GH stimulation tests;
  • The bone age (BA) ≤chronological age (CA)+6 months;
  • Prepubertal Status (Tanner Stage I);
  • Birth weight within the normal range;
  • Growth hormone treatment-naive;
  • Participants 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:

  • Participants with abnormal liver and kidney functions (ALT \> upper limit 1.5 times of normal value; Cr \> upper limit of normal value);
  • Participants are positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests;
  • Participants with known highly allergic constitution or allergy to investigational product or its excipient;
  • Participants with systemic chronic disease and immune deficiency;
  • Participants diagnosed with tumor, or with potential high tumor risks such as tumor markers exceed normal range and some other relative information may be excluded from the treatment;
  • Participants with mental disease;
  • Participants 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 participants, for both male and female participants);
  • Laron syndrome (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).
  • Participants with impaired glucose regulation (IGR) (including impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) ) or diabetes;
  • BMI (Body mass index) ≥22kg/m²;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Henan Children's Hospital

Zhengzhou, Henan, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

Children's Hospital of Shanxi

Taiyuan, Shanxi, China

RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

The Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Children's Hospital of Fudan University

Shanghai, China

RECRUITING

Children's Hospital of Shanghai

Shanghai, China

RECRUITING

Related Publications (1)

  • Yuan J, Fu J, Wei H, Zhang G, Xiao Y, Du H, Gu W, Li Y, Chen L, Luo F, Zhong Y, Gong H. A Randomized Controlled Phase 3 Study on the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Idiopathic Short Stature. Front Endocrinol (Lausanne). 2022 Apr 29;13:864908. doi: 10.3389/fendo.2022.864908. eCollection 2022.

    PMID: 35573994DERIVED

MeSH Terms

Conditions

Dwarfism

Condition Hierarchy (Ancestors)

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

Study Officials

  • Junfen Fu, Doctor

    The Children's Hospital of Zhejiang University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohua Feng

CONTACT

0431-85170552fengxiaohua@gensci-china.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2018

First Posted

August 17, 2018

Study Start

June 11, 2018

Primary Completion

October 1, 2021

Study Completion

October 30, 2021

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

CN(9)