Establishing Dose of Sr-hGH in ISS PatientsPhase 2NCT02042170
Efficacy and Safety Study of Sr-hGH in Comparison With Daily hGH in ISS Patients
A Phase 2 study testing human growth hormone self-injection in people with Establishing Dose of Sr-hGH in ISS Patients, run by LG Life Sciences at 1 site in South Korea.
Trial summary
The purpose of this study is to assess dosing requirements and establish the efficacy of SR-hGH in idiopathic short stature patients (ISS). This phase II study is designed as multi-center, randomized, active comparator-controlled, parallel, open-label. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Establishing Dose of Sr-hGH in ISS Patients
- What is being tested?
- human growth hormone self-injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Mar 2015
- Phase
- Phase 2
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Criteria
- are older than or equal to age of 4
- are pre-pubertal (Tanner's stage I)
- are younger than bone age of 9 in female; of 11 in male
- have less than 3 years of a difference in bone and chronological age
- have confirmed idiopathic short stature
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Multi-center, Randomized, Comparative, Parallel, Open, Dose Finding Study to Assess the Efficacy and Safety After 26 Week-treatment of Eutropin Plus (SR-hGH) Compared to Eutropin Inj. in Pre-pubertal Children With Idiopathic Short Stature
The purpose of this study is to assess dosing requirements and establish the efficacy of SR-hGH in idiopathic short stature patients (ISS). This phase II study is designed as multi-center, randomized, active comparator-controlled, parallel, open-label.
45 patients were randomized to three arms with 1:1:1 ratio, two arms of Sr-hGH and one of daily hGH. Two doses of Sr-hGH were administered, which are 0.5 and 0.7mg/kg/week. And the other arm received daily hGH at 0.37 mg/kg/week.
Read more
Patients in Sr-hGH groups injected on a specific day of the every week for 26 weeks. And patients randomized to daily hGH group injected for 6 days a week.
Patients visited study centers five times, firstly at screening (Visit 1), at randomization (Visit 2), after 13th dosing (Visit 3), after 26th dosing (Visit 4), and finally for follow-up (Visit5).
- Being tested
- human growth hormone self-injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human growth hormone self-injectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Sr-hGH 0.5 mg/kg/wk | Experimental | Patients inject Eutropin plus (Sr-hGH) 0.5 mg/kg/wk every week himself/herself. Receives: Drug: human growth hormone self-injection |
| Sr-hGH 0.7 mg/kg/wk | Experimental | Patients inject Eutropin plus (Sr-hGH) 0.7 mg/kg/wk every week himself/herself. Receives: Drug: human growth hormone self-injection |
| Daily hGH 0.37 mg/kg/wk | Active comparator | Patients inject Eutropin (daily hGH) 0.37 mg/kg/wk everyday for the first 6days a week himself/herself. Receives: Drug: human growth hormone self-injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in height velocity at Week 26, cm/year
Measured: Week 0-26
Secondary outcomes (3)
Change from baseline in height velocity, cm/year
Measured: at Week 13
Change from baseline in height, cm
Measured: at Week 13 and 26
Change from baseline in IGF (Insulin-like growth factor)-I and IGF-I SDS (standard deviation score)
Measured: at Week 13 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Establishing Dose of Sr-hGH in ISS PatientsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 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
- NCT02042170
- Sponsor's protocol ID
- LG-SHCL010
- Status last verified
- Sep 2015
- First submitted
- 20 Jan 2014
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-center, Randomized, Comparative, Parallel, Open, Dose Finding Study to Assess the Efficacy and Safety After 26 Week-treatment of Eutropin Plus (SR-hGH) Compared to Eutropin Inj. in Pre-pubertal Children With Idiopathic Short Stature
- ClinicalTrials.gov ID
- NCT02042170
- Acronym / sponsor ID
- LG-SHCL010
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Jan 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.
The purpose of this study is to assess dosing requirements and establish the efficacy of SR-hGH in idiopathic short stature patients (ISS). This phase II study is designed as multi-center, randomized, active comparator-controlled, parallel, open-label.
45 patients were randomized to three arms with 1:1:1 ratio, two arms of Sr-hGH and one of daily hGH. Two doses of Sr-hGH were administered, which are 0.5 and 0.7mg/kg/week. And the other arm received daily hGH at 0.37 mg/kg/week.
Patients in Sr-hGH groups injected on a specific day of the every week for 26 weeks. And patients randomized to daily hGH group injected for 6 days a week.
Patients visited study centers five times, firstly at screening (Visit 1), at randomization (Visit 2), after 13th dosing (Visit 3), after 26th dosing (Visit 4), and finally for follow-up (Visit5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sr-hGH 0.5 mg/kg/wk | Experimental | Drug: human growth hormone self-injectionPatients inject Eutropin plus (Sr-hGH) 0.5 mg/kg/wk every week himself/herself. |
| Sr-hGH 0.7 mg/kg/wk | Experimental | Drug: human growth hormone self-injectionPatients inject Eutropin plus (Sr-hGH) 0.7 mg/kg/wk every week himself/herself. |
| Daily hGH 0.37 mg/kg/wk | Active comparator | Drug: human growth hormone self-injectionPatients inject Eutropin (daily hGH) 0.37 mg/kg/wk everyday for the first 6days a week himself/herself. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| human growth hormone self-injection | Drug | Daily hGH 0.37 mg/kg/wk, Sr-hGH 0.5 mg/kg/wk, Sr-hGH 0.7 mg/kg/wk |
Primary outcome
Change from baseline in height velocity at Week 26, cm/year
Time frame: Week 0-26
3 secondary outcomes
Change from baseline in height velocity, cm/year
Time frame: at Week 13
Change from baseline in height, cm
Time frame: at Week 13 and 26
Change from baseline in IGF (Insulin-like growth factor)-I and IGF-I SDS (standard deviation score)
Time frame: at Week 13 and 26
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 24 Mar 2016.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing human growth hormone self-injection in people with Establishing Dose of Sr-hGH in ISS Patients, run by LG Life Sciences at 1 site 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?
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 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 velocity at Week 26, cm/year (time frame: Week 0-26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2016.