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Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA and ISS in Children (LGS)

This study is currently recruiting participants.
Verified March 2016 by LG Life Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT01604395
First Posted: May 23, 2012
Last Update Posted: March 23, 2016
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.
Information provided by (Responsible Party):
LG Life Sciences
May 21, 2012
May 23, 2012
March 23, 2016
January 2012
January 2020   (Final data collection date for primary outcome measure)
Safety measure : adverse event [ Time Frame: up to 2 years after epiphyseal closure ]
Same as current
Complete list of historical versions of study NCT01604395 on ClinicalTrials.gov Archive Site
  • effectiveness measure : difference in target height and final height [ Time Frame: up to 2 years after epiphyseal closure ]
  • effectiveness : difference in height velocity between Baseline and every year [ Time Frame: up to 2 years after epiphyseal closure ]
  • effectiveness measure : difference in height SDS for CA between baseline and every 6 months [ Time Frame: up to 2 years after epiphyseal closure ]
  • efficacy measure : difference in target height and final height [ Time Frame: up to 2 years after epiphyseal closure ]
  • efficacy : difference in height velocity between Baseline and every year [ Time Frame: up to 2 years after epiphyseal closure ]
  • efficacy measure : difference in height SDS for CA between baseline and every 6 months [ Time Frame: up to 2 years after epiphyseal closure ]
Not Provided
Not Provided
 
Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA and ISS in Children
An Open, Multi-center, Prospective and Retrospective Observational Study to Evaluate the Long-term Safety and Effectiveness of Growth Hormone (Eutropin Inj. / Eutropin Plus Inj.) Treatment With GHD, TS, CRF, SGA and ISS in Children
The purpose of this study is to evaluate the long-term safety and effectiveness of growth hormone (Eutropin Inj./Eutropin plus Inj.) treatment with GHD (Growth Hormone Deficiency), TS (Turner Syndrome),CRF (Chronic Renal Failure), SGA (Small for Gestational Age), and ISS (Idiopathic Short Stature).
Not Provided
Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample
children with GHD, TS, CRF, SGA and ISS
  • Growth Hormone Deficiency
  • Turner Syndrome
  • Chronic Renal Failure
  • Small for Gestational Age
  • Idiopathic Short Stature
Not Provided
growth hormone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
January 2022
January 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • short stature children aged 2 years or more
  • children with GHD,TS, CRF, SGA or ISS
  • written informed consent from the person, person's parent or legal guardian
Sexes Eligible for Study: All
2 Years and older   (Child, Adult, Senior)
No
Contact: YoungHwan Jang 82-2-6924-3158 younghj@lgls.com
Korea, Republic of
 
 
NCT01604395
LG-HGOS001
Yes
Not Provided
Not Provided
LG Life Sciences
LG Life Sciences
Not Provided
Principal Investigator: HW Chae, M.D. Kangnam severance hospital
Principal Investigator: KS Sim, M.D. Kangdong KyungHee University hospital
Principal Investigator: IT Hwang, M.D. Kangdong Sacred Heart Hospital
Principal Investigator: SC Chung, M.D. Konkook University hospital
Principal Investigator: CW Ko, M.D. Kyungpook National University
Principal Investigator: HS Kim, M.D. Keimyung University hospital
Principal Investigator: YJ Lee, M.D. Korea University
Principal Investigator: KH Lee, M.D. Korea University Anam Hospital
Principal Investigator: JH Lee, M.D. Kosin university hospital
Principal Investigator: JS Yu, M.D. Dankook University
Principal Investigator: JH Yu, M.D. Dong-A University Hospital
Principal Investigator: SY Lee, M.D. SMG-SNU Boramae Medical Center
Principal Investigator: WY Chung, M.D. Inje University
Principal Investigator: Yl Shin, M.D. Buchun Soonchunhyang university hospital
Principal Investigator: CY Kim, M.D. daejin medical center
Principal Investigator: DK Jin, M.D. Samsung Medical Center
Principal Investigator: MJ Park, M.D. Inje University
Study Chair: CH Shin, M.D. Seoul National University Hospital
Principal Investigator: BK Suh, M.D. Seoul St. Mary's Hospital
Principal Investigator: HW Yoo, M.D. Asan Medical Center
Principal Investigator: MH Jung, M.D. Yeouide St. Mary's hospital
Principal Investigator: SH Park, M.D. St. Vincent's Medical Center
Principal Investigator: DH Kim, M.D. Sowha children's hospital
Principal Investigator: DH Lee, M.D. Seoul Soonchunhyang university hospital
Principal Investigator: HS Kim, M.D. Sinchon severance hospital
Principal Investigator: JS Hwang, M.D. Ajou University School of Medicine
Principal Investigator: SY Kim, M.D. Pusan National University Yangsan Hospital
Principal Investigator: JD Kim, M.D. Wonkwang university school of medicine & hospital
Principal Investigator: HS Han, M.D. Chungbuk National University Hospital
Principal Investigator: KH Lee, M.D. Wonkwang University Sanbon Medical Center
Principal Investigator: EK Yoo, M.D. Bunsangcha hospital
Principal Investigator: BK Lim, M.D. Wonju Christian Hospital
Principal Investigator: JH Kang, M.D. Eulji University Hospital
Principal Investigator: JY Seo, M.D. Eulji General Hospital
Principal Investigator: HS Kim, M.D. ehwa university medical center
Principal Investigator: JE Lee, M.D. Inha University Hospital
Principal Investigator: JH Kim, M.D. Inje University
Principal Investigator: CJ Kim, M.D. Chonnam National University Hospital
Principal Investigator: DY Lee, M.D. Chonbuk National University Hospital
Principal Investigator: KS Shin, M.D. Jeju National University Hospital
Principal Investigator: IT Hwang, M.D. Hallym University Medical Center
Principal Investigator: SM Lee, M.D. Hanyang University
Principal Investigator: KH Lee, M.D. Korea University Guro Hospital
Principal Investigator: KS Jo, M.D. Bucheon St. Mary's Hospital
Principal Investigator: SY Ahn, M.D. KangWon National University Hospital
Principal Investigator: PS Oh, M.D. Chuncheon Sacred Heart Hospital
Principal Investigator: S Yang, M.D. Hallym University Kangnam Sacred Heart Hospital
Principal Investigator: EY Kim, M.D. Chosun University Hospital
LG Life Sciences
March 2016