Prader-Willi SyndromePhase 3NCT02204163
Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome
A Phase 3 study testing Eutropin and Genotropin in people with Prader-Willi Syndrome, run by LG Life Sciences at 3 sites in South Korea.
Trial summary
Evaluate the efficacy and safety after treatment of Eutropin® inj. compared to Genotropin® in infants/toddlers with Prader-Willi syndrome Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- Eutropin and Genotropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jun 2014to Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pediatric patients with PWS confirmed by methylation PCR genetic testing
- Prepubertal pediatric patients (Tanner's Pubertal stage I) at screening
- 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
- Pediatric patients with normal thyroid function at screening (Those with normal function through a hormonal therapy were allowable.)
- 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.
Who cannot join
- 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.
- Pediatric patients with malignancy or a history of malignancy at screening
- 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.
- Pediatric patients with impaired fasting glucose, diabetes, and diabetic retinopathy at screening
- Pediatric patients whose epiphyses are closed with a growth rate of ≤1 cm/year at screening
Show all 11Show fewer
- 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.)
- Pediatric patients who are being administered any drug (e.g. methylphenidate) for treatment of hyperactivity disorders including attention deficit hyperactivity disorder (ADHD) at screening
- 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
- 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
- Pediatric patients in whom this clinical study is considered to be difficult to be conducted for any other reasons on investigator's judgment
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Ajou University Hospital
Suwon
About this study
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
Evaluate the efficacy and safety after treatment of Eutropin® inj. compared to Genotropin® in infants/toddlers with Prader-Willi syndrome
- Conditions
- Prader-Willi Syndrome
- Being tested
- Eutropin, Genotropin
- Medical subject headings
- Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EutropinDrug
GenotropinDrug
| Study group | Role | What they receive |
|---|---|---|
| Eutropin | Experimental | Eutropin 0.24mg/kg/week Receives: Drug: Eutropin |
| Genotropin | Active comparator | Genotropin 0.24mg/kg/week Receives: Drug: Genotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in height SDS (Standard Deviation Score)
Measured: baseline and 52 weeks
Change from baseline in Lean body mass (g)
Measured: baseline and 52 weeks
Change from baseline in Percent body fat (%)
Measured: baseline and 52 weeks
Secondary outcomes (12)
Change from baseline in height velocity (cm/year)
Measured: baseline, 16, 28 and 52 weeks
Change from baseline in head circumference (cm)
Measured: baseline, 16, 28 and 52 weeks
Change from baseline in cognitive development (score) by Bayley Scale
Measured: baseline, 28 and 52 weeks
Change from baseline in motor development (score) by Bayley Scale
Measured: baseline, 28 and 52 weeks
Change from baseline in weight SDS
Measured: baseline 16, 28 and 52 weeks
Change from baseline in BMI (kg/m2) (Body Mass Index)
Measured: baseline, 16, 28 and 52 weeks
Change from baseline in Bone age (month)
Measured: baseline and 52 weeks
Change from baseline in Bone mineral density (g/cm)
Measured: baseline and 52 weeks
Change from baseline in height (cm)
Measured: baseline, 16, 28 and 52 weeks
Change from baseline in height SDS
Measured: baseline, 16 and 28 weeks
Change from baseline in IGF-1 (ng/mL) and IGF-1 SDS
Measured: baseline, 28, and 52 weeks
Change from baseline in IGFBP-3 (ng/mL) and IGFBP-3 SDS
Measured: baseline, 28, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204163
- Sponsor's protocol ID
- LG-HGCL007
- Status last verified
- Jun 2019
- First submitted
- 25 Jul 2014
- Last updated
- 27 Jun 2019
- Results posted
- No
Publications
Yang A, Choi JH, Sohn YB, Eom Y, Lee J, Yoo HW, Jin DK. Effects of recombinant human growth hormone treatment on growth, body composition, and safety in infants or toddlers with Prader-Willi syndrome: a randomized, active-controlled trial. Orphanet J Rare Dis. 2019 Sep 11;14(1):216. doi: 10.1186/s13023-019-1195-1.
PubMed 31511031
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02204163
- Acronym / sponsor ID
- LG-HGCL007
- Conditions
- Prader-Willi Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy and safety after treatment of Eutropin® inj. compared to Genotropin® in infants/toddlers with Prader-Willi syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eutropin | Experimental | Drug: EutropinEutropin 0.24mg/kg/week |
| Genotropin | Active comparator | Drug: GenotropinGenotropin 0.24mg/kg/week |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (11 listed)
- : 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eutropin | Drug | Eutropin |
| Genotropin | Drug | Genotropin |
Primary outcome
Change from baseline in height SDS (Standard Deviation Score)
Time frame: baseline and 52 weeks
Change from baseline in Lean body mass (g)
Time frame: baseline and 52 weeks
Change from baseline in Percent body fat (%)
Time frame: baseline and 52 weeks
12 secondary outcomes
Change from baseline in height velocity (cm/year)
Time frame: baseline, 16, 28 and 52 weeks
Change from baseline in head circumference (cm)
Time frame: baseline, 16, 28 and 52 weeks
Change from baseline in cognitive development (score) by Bayley Scale
Time frame: baseline, 28 and 52 weeks
Change from baseline in motor development (score) by Bayley Scale
Time frame: baseline, 28 and 52 weeks
Change from baseline in weight SDS
Time frame: baseline 16, 28 and 52 weeks
Change from baseline in BMI (kg/m2) (Body Mass Index)
Time frame: baseline, 16, 28 and 52 weeks
Change from baseline in Bone age (month)
Time frame: baseline and 52 weeks
Change from baseline in Bone mineral density (g/cm)
Time frame: baseline and 52 weeks
Change from baseline in height (cm)
Time frame: baseline, 16, 28 and 52 weeks
Change from baseline in height SDS
Time frame: baseline, 16 and 28 weeks
Change from baseline in IGF-1 (ng/mL) and IGF-1 SDS
Time frame: baseline, 28, and 52 weeks
Change from baseline in IGFBP-3 (ng/mL) and IGFBP-3 SDS
Time frame: baseline, 28, and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Derived from this study: PubMed 31511031Yang A, Choi JH, Sohn YB, Eom Y, Lee J, Yoo HW, Jin DK. Effects of recombinant human growth hormone treatment on growth, body composition, and safety in infants or toddlers with Prader-Willi syndrome: a randomized, active-controlled trial. Orphanet J Rare Dis. 2019 Sep 11;14(1):216. doi: 10.1186/s13023-019-1195-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eutropin and Genotropin in people with Prader-Willi Syndrome, run by LG Life Sciences at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in height SDS (Standard Deviation Score) (time frame: baseline and 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02204163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.