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:
LG Life Sciences
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
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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:
Genetics Home Reference related topics:
combined pituitary hormone deficiency
isolated growth hormone deficiency
metatropic dysplasia
persistent Müllerian duct syndrome
pseudoachondroplasia
tetrasomy 18p
Turner syndrome
Drug Information available for:
Somatropin
U.S. FDA Resources
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. | Yonsei University |
| 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 May 23, 2013