Trial record 12 of 34 for:    Open Studies | "Turner Syndrome"

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 June 2012 by LG Life Sciences
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01604395
First received: May 21, 2012
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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).


Condition
Growth Hormone Deficiency
Turner Syndrome
Chronic Renal Failure
Small for Gestational Age
Idiopathic Short Stature

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: An Open, Multi-center, Prospective and Retrospective Observational Study to Access the Long-term Safety and Effectiveness of Growth Hormone (Eutropin Inj. / Eutropin Plus Inj.) Treatment With GHD, TS, CRF, SGA and ISS in Children

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Safety measure : adverse event [ Time Frame: up to 2 years after epiphyseal closure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • effectiveness measure : difference in target height and final height [ Time Frame: up to 2 years after epiphyseal closure ] [ Designated as safety issue: No ]
  • effectiveness : difference in height velocity between Baseline and every year [ Time Frame: up to 2 years after epiphyseal closure ] [ Designated as safety issue: No ]
  • effectiveness measure : difference in height SDS for CA between baseline and every 6 months [ Time Frame: up to 2 years after epiphyseal closure ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: January 2012
Groups/Cohorts
growth hormone

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

children with GHD, TS, CRF, SGA and ISS

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604395

Contacts
Contact: YoungHwan Jang 82-2-6924-3158 younghj@lgls.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: CH Shin, M.D.         
Principal Investigator: CH Shin, M.D.         
Sponsors and Collaborators
LG Life Sciences
Investigators
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. Kyungbook national university hospital
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. Seoul National University 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 Hospital.
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
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. Kangnam Sacred Heart hospital
Principal Investigator: EY Kim, M.D. Chosun University Hospital
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01604395     History of Changes
Other Study ID Numbers: LG-HGOS001
Study First Received: May 21, 2012
Last Updated: June 12, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by LG Life Sciences:
GHD
TS
CRF
SGA
ISS

Additional relevant MeSH terms:
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Dwarfism
Dwarfism, Pituitary
Kidney Failure, Chronic
Renal Insufficiency
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 17, 2014