NCT03255694

Brief Summary

After the first stage (52 weeks) of Phase II clinical trial, Pegylated recombinant human growth hormone (PEG-rhGH) injection of appropriate dose in compliance with ISS clinical treatment strategy is used to treat children with ISS (Idiopathic Short Stature). The long-term efficacy and safety of the investigational product are evaluated, which can provide more scientific and reliable medication guidance information for clinical diagnosis and treatment.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for phase_2

Timeline
50mo left

Started May 2017

Longer than P75 for phase_2

Geographic Reach
1 country

12 active sites

Status
active not recruiting

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 Progress69%
May 2017Jun 2030

Study Start

First participant enrolled

May 12, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

13.1 years

First QC Date

July 14, 2017

Last Update Submit

August 12, 2025

Conditions

Dwarfism

Outcome Measures

Primary Outcomes (1)

  • Change of yearly height velocity (ΔHV)

    Change of yearly height velocity before and after treatment. Yearly Height Velocity=12×(Height Yx - Height at Baseline)/(Date of Yx - Date of Baseline)(Yx refers to the height value at particular timepoint x)

    Baseline，the end of 3-year addendum

Secondary Outcomes (14)

  • Standard deviation score of height at the actual age (ΔHT SDS)

    Baseline，every 3 months，the end of 3-year addendum

  • Change fo Bone maturation

    Baseline，every 3 months，the end of 3-year addendum

  • Change of IGF-1 SDS (ΔIGF-1 SDS)

    Baseline，every 3 months，the end of 3-year addendum

  • Changes of standard deviation scores of body mass index (ΔBMI SDS)

    Baseline，every 3 months，the end of 3-year addendum

  • The yearly average dose of PEG-rhGH injection

    Baseline，every 3 months，the end of 3-year addendum

  • +9 more secondary outcomes

Study Arms (1)

PEG-somatropin

EXPERIMENTAL

After the first stage (52 weeks) of Phase II clinical trial, the initial medication dose of this extension period is 0.2 mg/kg weight/week of PEG-rhGH for the high dose group, low dose group and negative control group, and it is adjusted in accordance with yearly height velocity (HV) and IGF-1 SDS of each visit. The maximum dose shall not exceed 0.4 mg/kg weight/week.

Drug: PEG-somatropin

Interventions

PEG-somatropinDRUG

After the first stage (52 weeks) of Phase II clinical trial, the initial medication dose of this extension period is 0.2 mg/kg weight/week of PEG-rhGH for high dose group, low dose group and negative control group, and it is adjusted in accordance with yearly height velocity (HV) and IGF-1 SDS of each visit. The maximum dose shall not exceed 0.4 mg/kg weight/week.

Also known as: Polyethylene Glycol Recombinant Human Somatropin Injection
PEG-somatropin

Eligibility Criteria

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

You may qualify if:

  • All subjects who have completed the first stage (52 weeks) of Phase II clinical trial (including negative controls) with completed follow-up records may be enrolled in the extension period study.
  • Before the extension period study, the investigator shall fully inform the subjects and their guardians of all the information about the extension period study, including detailed follow-up procedure, treatment plan, laboratory examination items during follow-ups and possible benefits and risks. The extension period study shall only be initiated after the subjects and their guardians are well informed, and agree to cooperate and complete the treatment, follow-ups and examinations during the study, and sign the written informed consent.

You may not qualify if:

  • Subjects who have taken the following medications within 2 months before entering the extension period study:
  • Aromatase inhibitors (which include but are not limited to Lelrozol and Anastrozole), with continuous medication ≥1 month;
  • Gonadotropin releasing hormone analogues (which include but are not limited to Triptorelin, Leuprorelin and Goserelin),, with continuous medication ≥1 month;
  • Sex steroids (which include but are not limited to any type of estrogen, progestin and androgen) , with continuous medication ≥1 month;
  • Protein anabolic drugs (which include but are not limited to Oxandrolone, Danazol and Strombafort), with continuous medication ≥1 month;
  • Glucocorticoids via oral/intravenous administration for more than 1 month..

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Beijing Children's Hospital, Capital Medical University, National Center for Children's Health

Beijing, Beijing Municipality, China

Location

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

Wuhan, Hubei, China

Location

Hunan Children's Hospital

Changsha, Hunan, China

Location

Children's Hospital of Soochow University

Naning, Jiangsu, China

Location

The First Affiated Hospital of Nanjing Medical Universit

Nanjing, Jiangsu, China

Location

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Location

Wuxi Children's Hospital

Wuxi, Jiangsu, China

Location

Jiangxi Provincial Children's Hospital

Nanchang, Jiangxi, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Shanghai Children's Hospital of Fudan University

Shanghai, China

Location

Shanghai Children's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Dwarfism

Condition Hierarchy (Ancestors)

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

Study Officials

  • Xiaoping Luo

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2017

First Posted

August 21, 2017

Study Start

May 12, 2017

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Last Updated

August 15, 2025

Record last verified: 2025-08

Locations

CN(12)