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Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02204163
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

Brief Summary:
Evaluate the efficacy and safety after treatment of Eutropin® inj. compared to Genotropin® in infants/toddlers with Prader-Willi syndrome

Condition or disease Intervention/treatment Phase
Prader-Willi Syndrome Drug: Eutropin Drug: Genotropin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Multi-center, Randomized, Comparative, Parallel, Open Study to Assess the Efficacy and Safety After Treatment of Eutropin® Inj. Compared to Genotropin® in Infants/Toddlers With Prader-Willi Syndrome
Study Start Date : June 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: Eutropin
Eutropin 0.24mg/kg/week
Drug: Eutropin
Active Comparator: Genotropin
Genotropin 0.24mg/kg/week
Drug: Genotropin



Primary Outcome Measures :
  1. Change from baseline in height SDS (Standard Deviation Score) [ Time Frame: baseline and 52 weeks ]
  2. Change from baseline in Lean body mass (g) [ Time Frame: baseline and 52 weeks ]
  3. Change from baseline in Percent body fat (%) [ Time Frame: baseline and 52 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in height velocity (cm/year) [ Time Frame: baseline, 16, 28 and 52 weeks ]
  2. Change from baseline in head circumference (cm) [ Time Frame: baseline, 16, 28 and 52 weeks ]
  3. Change from baseline in cognitive development (score) by Bayley Scale [ Time Frame: baseline, 28 and 52 weeks ]
  4. Change from baseline in motor development (score) by Bayley Scale [ Time Frame: baseline, 28 and 52 weeks ]
  5. Change from baseline in weight SDS [ Time Frame: baseline 16, 28 and 52 weeks ]
  6. Change from baseline in BMI (kg/m2) (Body Mass Index) [ Time Frame: baseline, 16, 28 and 52 weeks ]
  7. Change from baseline in Bone age (month) [ Time Frame: baseline and 52 weeks ]
  8. Change from baseline in Bone mineral density (g/cm) [ Time Frame: baseline and 52 weeks ]
  9. Change from baseline in height (cm) [ Time Frame: baseline, 16, 28 and 52 weeks ]
  10. Change from baseline in height SDS [ Time Frame: baseline, 16 and 28 weeks ]
  11. Change from baseline in IGF-1 (ng/mL) and IGF-1 SDS [ Time Frame: baseline, 28, and 52 weeks ]
  12. Change from baseline in IGFBP-3 (ng/mL) and IGFBP-3 SDS [ Time Frame: baseline, 28, and 52 weeks ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Inclusion Criteria:

    1. Pediatric patients with PWS confirmed by methylation PCR genetic testing
    2. Prepubertal pediatric patients (Tanner's Pubertal stage I) at screening
    3. Pediatric patients who have never been treated with hGH prior to screening, or who had been treated with hGH for less than 6 months if they had a treatment history, and whose last administration was made 6 months prior to screening
    4. Pediatric patients with normal thyroid function at screening (Those with normal function through a hormonal therapy were allowable.)
    5. Pediatric patients whose parents or LARs signed the informed consent form in writing after receiving the explanation about the purpose, method, effects, etc. of the clinical study, and who also signed the informed consent form in writing if they are capable of reading and understanding writing.
  • Exclusion Criteria:

    1. Pediatric patients who are accompanied by other causes for growth retardation as follows except for PWS at screening

      : Chronic renal failure (including the case in which renal transplantation has been undergone), Silver-Russell syndrome, Turner's syndrome, Seckel syndrome, Down's syndrome, Noonan syndrome, Cushing's syndrome, congenital infections, psychiatric disorders, chronic debilitating diseases, etc.

    2. Pediatric patients with malignancy or a history of malignancy at screening
    3. Pediatric patients with severe respiratory disturbance, or sleep apnoea or a history of respiratory infections with an unknown cause at screening. However, those whose condition had been confirmed to be eligible to participate in the clinical study on investigator's judgment were allowed to participae in the study.
    4. Pediatric patients with impaired fasting glucose, diabetes, and diabetic retinopathy at screening
    5. Pediatric patients whose epiphyses are closed with a growth rate of ≤1 cm/year at screening
    6. Pediatric patients who are being administered any drug that may have an effect on the secretion and actions of hGH (estrogen, androgen, anabolic steroids, corticosteroids, GnRH analogs, thyroxine, aromatase inhibitors, etc.) or anticonvulsants and cyclosporin at screening, and have been administered any of them for a long period of time within 6 months prior to screening (However, those who have been administered a thyroxine preparation for ≥4 weeks on a stable dose [allowable in case the investigator determines the dose is stable even though it is changeable based upon the weight of the pediatric patient] were allowed to participate in the clinical study.)
    7. Pediatric patients who are being administered any drug (e.g. methylphenidate) for treatment of hyperactivity disorders including attention deficit hyperactivity disorder (ADHD) at screening
    8. Pediatric patients who are hypersensitive to somatropin or any excipient of the investigational product (cresol or glycerol) or who have a relevant history of hypersensitivity
    9. Pediatric patients who have participated in any other clinical studies after enrolled in this study or who had participated in any other clinical studies within 3 months prior to enrollment in this clinical study
    10. Pediatric patients in whom this clinical study is considered to be difficult to be conducted for any other reasons on investigator's judgment

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): NCT02204163


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT02204163    
Other Study ID Numbers: LG-HGCL007
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders