A Study Extension Period of PEG-somatropin (Pegylated-somatropin) in the Treatment of Children With Idiopathic Short Stature

Phase 2Active Not RecruitingNCT03255694

Changchun GeneScience Pharmaceutical Co., Ltd.360 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

360

Conditions

Dwarfism

Interventions

PEG-somatropinDRUG

Eligibility

Sex: ALLMin age: 4 YearsMax age: 9 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * Subjects who have taken the following medications within 2 months before entering the extension period study: 1. Aromatase inhibitors (which include but are not limited to Lelrozol and Anastrozole), with continuous medication ≥1 month; 2. Gonadotropin releasing hormone analogues (which include but are not limited to Triptorelin, Leuprorelin and Goserelin),, with continuous medication ≥1 month; 3. Sex steroids (which include but are not limited to any type of estrogen, progestin and androgen) , with continuous medication ≥1 month; 4. Protein anabolic drugs (which include but are not limited to Oxandrolone, Danazol and Strombafort), with continuous medication ≥1 month; 5. Glucocorticoids via oral/intravenous administration for more than 1 month..

Locations (12)

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

Beijing, Beijing Municipality, China

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

Wuhan, Hubei, China

Hunan Children's Hospital

Changsha, Hunan, China

Children's Hospital of Soochow University

Naning, Jiangsu, China

The First Affiated Hospital of Nanjing Medical Universit

Nanjing, Jiangsu, China

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Wuxi Children's Hospital

Wuxi, Jiangsu, China

Jiangxi Provincial Children's Hospital

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

...and 2 more locations

Outcomes

Primary Outcomes

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)

Time frame: Baseline，the end of 3-year addendum