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Infant, Small for Gestational AgePhase 3SGANCT02770157

Efficacy and Safety of DA-3002 in Short Children Borns SGA.

A Phase 3 study testing DA-3002 and Genotropin® in people with Infant, Small for Gestational Age, run by Dong-A ST Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short children born small for gestational age. Read more about this study

Who is it for?
Ages 4 to 16 years
Conditions the study is for
Infant, Small for Gestational Age
What is being tested?
DA-3002 and Genotropin®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteSouth Korea
Study dates
26 Feb 2016to 28 Aug 2019
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 4 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Chronological Age ≥ 4
  • Before the adolescence, Tuner stage I (breast)
  • Height <3rd percentile for age
  • Normal thyroid function

Who cannot join

  • Growth hormone was administered for 12 months or longer in the past
  • Treated with estrogen or adrenal androgens for 12 months or longer in the past
  • Malignancy, CNS Trauma, Psychiatric Disorder
  • endocrine and/or metabolic disorders
  • growth failure caused by other disorders

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Phase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Short Children Born Small for Gestational Age.

A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short children born small for gestational age.

Being tested
DA-3002, Genotropin®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DA-3002Drug

  • Genotropin®Drug

Study groups in NCT02770157
Study groupRoleWhat they receive
DA-3002Experimental1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(six or seven times per week).
Receives: Drug: DA-3002
Genotropin®Active comparator1.44 IU (0.48mg)/kg/week of Genotropin is injected for 52 weeks by changing injecting areas(six or seven times per week).
Receives: Drug: Genotropin®
Non-treatment control groupOtherAfter no treatment for 26 weeks, 1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(six or seven times per week).
Receives: Drug: DA-3002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized height velocity(cm/year) after 52 weeks.

    Height velocity calculated with height measured at Baseline and after 52 weeks was converted to annual growth rate.

    Measured: 52 weeks

Secondary outcomes (5)

  1. Annualized height velocity(cm/year) after 26 weeks.

    Height velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.

    Measured: 26 weeks

  2. Changes in height standard deviation score after 52 weeks

    Measured: 52 weeks

  3. Changes in bone maturation(changes in bone ages/changes in chronological age) after 52 weeks

    Measured: 52 weeks

  4. Changes in IGF-1 after 52 weeks

    Measured: 52 weeks

  5. Changes in IGFBP-3 after 52 weeks

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2016 (estimated)
  2. Study start26 Feb 2016
  3. Primary completion28 Aug 2019
  4. Study completion28 Aug 2019

Resources

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
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02770157
Sponsor's protocol ID
DA3002_SGA_III
Acronym
SGA
Status last verified
Oct 2019
First submitted
10 May 2016
Last updated
16 Oct 2019
Results posted
No

Publications

  • Kim SJ, Kim MS, Cho SY, Suh BK, Ko CW, Lee KH, Yoo HW, Shin CH, Hwang JS, Kim HS, Chung WY, Kim CJ, Han HS, Jin DK. Efficacy and safety of the recombinant human growth hormone in short children born small for gestational age: A randomized, multicentre, comparative phase III trial. Medicine (Baltimore). 2021 Jul 30;100(30):e26711. doi: 10.1097/MD.0000000000026711.

    PubMed 34397702

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DA-3002 and Genotropin® in people with Infant, Small for Gestational Age, run by Dong-A ST Co., Ltd. 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?

The sponsor lists 4 inclusion and 5 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 16 Oct 2019. 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 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?

Annualized height velocity(cm/year) after 52 weeks. (time frame: 52 weeks). 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 NCT02770157, 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 16 Oct 2019.

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