Turner's SyndromePhase 3NCT01813630

A Clinical Study to Assess the Efficacy and Safety of DA-3002

A Phase 3 study testing DA-3002 and Genotropin® in people with Turner's Syndrome, 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®. Read more about this study

Who is it for?: Ages 2 to 12 years
Conditions the study is for: Turner's Syndrome
What is being tested?: DA-3002 and Genotropin®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteSouth Korea
Study dates: Feb 2013to May 2018
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 2 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Diagnosed with Turner's Syndrome through chromosome analysis
The chronological age: 2≤AGE≤12
The yearly growth rate should be less than 6cm; the bone age should be equal or less than 12; the height ≤ 10th percentile for the heights of their agemates
Before the adolescence, Tuner stage I (breast)
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

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 Patients With Turner's Syndrome

A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.

Conditions: Turner's Syndrome
Being tested: DA-3002, Genotropin®
Keywords: Turner's Syndrome, Short Stature, Dwarfism
Medical subject headings: Turner Syndrome, Dwarfism

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 NCT01813630
Study group	Role	What they receive
DA-3002	Experimental	0.14 IU (0.045-0.050mg)/kg/day of DA-3002 is injected for 52 weeks by changing injecting areas Receives: Drug: DA-3002
Genotropin®	Active comparator	0.14 IU (0.045-0.050mg)/kg/day of Genotropin is injected for 52 weeks by changing injecting areas Receives: Drug: Genotropin®

What is being measured

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

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 (4)

Changes in height standard deviation score after 52 weeks
Measured: 52 weeks
Changes in bone maturation(changes in bone ages/changes in chronological age)
Measured: 52 weeks
Changes in IGF-1
Measured: 52 weeks
Changes in IGFBP-3
Measured: 52 weeks

Timeline

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

Feb 2013May 2018

First posted19 Mar 2013 (estimated)
Study startFeb 2013
Primary completionMay 2018
Study completionMay 2018

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 Turner's 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: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01813630
Sponsor's protocol ID: DA3002_TS_III
Status last verified: Jul 2018
First submitted: 15 Mar 2013
Last updated: 26 Jul 2018
Results posted: No
Data monitoring committee: No

Publications

Kim J, Kim MS, Suh BK, Ko CW, Lee KH, Yoo HW, Shin CH, Hwang JS, Kim HS, Chung WY, Kim CJ, Han HS, Jin DK. Recombinant growth hormone therapy in children with Turner Syndrome in Korea: a phase III Randomized Trial. BMC Endocr Disord. 2021 Dec 10;21(1):243. doi: 10.1186/s12902-021-00904-5.
PubMed 34893062

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Not yet recruitingObservational study
Hematological Profile in Children With Numerical Chromosomal Disorders
Down Syndrome, Turner Syndrome
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
Active, not recruitingPhase 2
Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
Hypothalamic Obesity, Hypothalamic Tumor

All Turner's Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Patients With Turner's Syndrome
ClinicalTrials.gov ID: NCT01813630
Acronym / sponsor ID: DA3002_TS_III
Conditions: Turner's Syndrome
Keywords: Turner's Syndrome, Short Stature, Dwarfism
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
Study start: Feb 2013 (actual)
Primary completion: May 2018 (actual)
Study completion: May 2018 (actual)
First posted: 19 Mar 2013 (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.

A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DA-3002	Experimental	Drug: DA-30020.14 IU (0.045-0.050mg)/kg/day of DA-3002 is injected for 52 weeks by changing injecting areas
Genotropin®	Active comparator	Drug: Genotropin®0.14 IU (0.045-0.050mg)/kg/day of Genotropin is injected for 52 weeks by changing injecting areas

Who may qualify

Ages: 2 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Diagnosed with Turner's Syndrome through chromosome analysis
The chronological age: 2≤AGE≤12
The yearly growth rate should be less than 6cm; the bone age should be equal or less than 12; the height ≤ 10th percentile for the heights of their agemates
Before the adolescence, Tuner stage I (breast)
Normal thyroid function

Key exclusion criteria (3 listed)

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

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
DA-3002	Drug	DA-3002
Genotropin®	Drug	Genotropin®

Primary outcome

Annualized height velocity(cm/year) after 52 weeks
Time frame: 52 weeks
Height velocity calculated with height measured at Baseline and after 52 weeks was converted to annual growth rate

4 secondary outcomes

Changes in height standard deviation score after 52 weeks
Time frame: 52 weeks
Changes in bone maturation(changes in bone ages/changes in chronological age)
Time frame: 52 weeks
Changes in IGF-1
Time frame: 52 weeks
Changes in IGFBP-3
Time frame: 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 26 Jul 2018.
Derived from this study: PubMed 34893062Kim J, Kim MS, Suh BK, Ko CW, Lee KH, Yoo HW, Shin CH, Hwang JS, Kim HS, Chung WY, Kim CJ, Han HS, Jin DK. Recombinant growth hormone therapy in children with Turner Syndrome in Korea: a phase III Randomized Trial. BMC Endocr Disord. 2021 Dec 10;21(1):243. doi: 10.1186/s12902-021-00904-5.

Related trials for Turner's Syndrome

RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Not yet recruitingObservational study
Hematological Profile in Children With Numerical Chromosomal Disorders
Down Syndrome, Turner Syndrome
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
Active, not recruitingPhase 2
Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
Hypothalamic Obesity, Hypothalamic Tumor

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.

Han Wook Yoo, M.D., Ph.D. principal investigator

Asan Medical Center

Byung Kyu Suh, M.D., Ph.D. principal investigator

Seoul St. Mary's Hospital, The Catholic University of Korea

Cheol Woo Ko, M.D., Ph.D. principal investigator

Kyungpook National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DA-3002 and Genotropin® in people with Turner's Syndrome, 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 5 inclusion and 3 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 26 Jul 2018. 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 NCT01813630, 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 26 Jul 2018.