ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 821 for:    SOMATROPIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03255694
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : August 21, 2017
Sponsor:
Collaborators:
Tongji Hospital
First Hospital of Jilin University
Affiliated Hospital of Jiangnan University
The First Affiliated Hospital with Nanjing Medical University
Shanghai Children's Hospital
The Children's Hospital of Zhejiang University School of Medicine
Children's Hospital of Fudan University
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Dwarfism Drug: PEG-somatropin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study Extension Period of Pegylated Somatropin (PEG-somatropin) in the Treatment of Children With Idiopathic Short Stature: An Open, Non-controlled Observational Study.
Actual Study Start Date : March 29, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dwarfism
Drug Information available for: Somatropin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PEG-somatropin
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
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.
Other Name: Polyethylene Glycol Recombinant Human Somatropin Injection



Primary Outcome Measures :
  1. Change of yearly height velocity (ΔHV) [ Time Frame: Baseline,the end of 3-year addendum ]
    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)


Secondary Outcome Measures :
  1. Standard deviation score of height at the actual age (ΔHT SDS) [ Time Frame: Baseline,every 3 months,the end of 3-year addendum ]
    Standard deviation score of height at the actual age.

  2. Change fo Bone maturation [ Time Frame: Baseline,every 3 months,the end of 3-year addendum ]
    Change fo Bone maturation before and after treatement (bone age/chronological age)

  3. Change of IGF-1 SDS (ΔIGF-1 SDS) [ Time Frame: Baseline,every 3 months,the end of 3-year addendum ]
    Change of IGF-1 SDS before and after treatement

  4. Changes of standard deviation scores of body mass index (ΔBMI SDS) [ Time Frame: Baseline,every 3 months,the end of 3-year addendum ]
    Changes of standard deviation scores of body mass index

  5. The yearly average dose of PEG-rhGH injection [ Time Frame: Baseline,every 3 months,the end of 3-year addendum ]
  6. Final height (FH) [ Time Frame: Baseline,every 3 months,the end of 3-year addendum ]
    Final height

  7. The improvement of FH compared with the baseline predicted adult height (PAH) [ Time Frame: Baseline,every 3 months,the end of 3-year addendum ]
  8. Improvement of NAH (near adult height) [ Time Frame: Baseline,every 3 months,the end of 3-year addendum ]
    For subjects who reach NAH with treatment but fail to follow-ups before reaching FH, the improvement of NAH in comparison with the baseline PAH (predicted adult height) shall be evaluated

  9. the improvement of PAH [ Time Frame: Baseline,every 3 months,the end of 3-year addendum ]
    For subjects who fail to reach NAH with treatment and fail to follow-ups before reaching FH, the improvement of PAH in comparison with the baseline PAH shall be evaluated

  10. The changes of the scores evaluated by the Quality of Life Scale [ Time Frame: Baseline,every 3 months,the end of 3-year addendum ]
  11. The changes of lean body mass (LBM) (optional) [ Time Frame: Baseline,every 3 months,the end of 3-year addendum ]
  12. The changes of fat mass (torso) (FM) (optional) [ Time Frame: Baseline,every 3 months,the end of 3-year addendum ]
  13. The changes of the percentage of body fat (optional) [ Time Frame: Baseline,every 3 months,the end of 3-year addendum ]
  14. The changes of bone mineral density (BMD) (optional) [ Time Frame: Baseline,every 3 months,the end of 3-year addendum ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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..

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255694


Contacts
Contact: Yanlin Chen +86-60871786-8197 chenyanlin@gensci-china.com

Locations
China, Hubei
Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan Recruiting
Wuhan, Hubei, China
Contact: Xiaoping Luo, PhD         
China, Jiangsu
The First Affiated Hospital of Nanjing Medical Universit Recruiting
Nanjing, Jiangsu, China
Contact: Yuhua Hu, MD         
Affiliated Hospital of Jiangnan University Recruiting
Wuxi, Jiangsu, China
Contact: Zhuangjian Xu, MD         
China, Jilin
The First Hospital of Jilin University Recruiting
Changchun, Jilin, China
Contact: Hongwei Du, MD         
China, Zhejiang
The Children's Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China
Contact: Junfen Fu, MD         
China
Shanghai Children's Hospital of Fudan University Recruiting
Shanghai, China
Contact: Feihong Luo, MD         
Shanghai Children's Hospital Recruiting
Shanghai, China
Contact: Pin Li, MD         
Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.
Tongji Hospital
First Hospital of Jilin University
Affiliated Hospital of Jiangnan University
The First Affiliated Hospital with Nanjing Medical University
Shanghai Children's Hospital
The Children's Hospital of Zhejiang University School of Medicine
Children's Hospital of Fudan University
Investigators
Principal Investigator: Xiaoping Luo Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03255694     History of Changes
Other Study ID Numbers: GenSci 033 CT-Extension Period
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases