Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature

NCT01786902 | Completed Phase 3 Results

• 1 other identifier: DA3002_ISS_III
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Growth hormone therapy will improve the height of idiopathic short statured children. DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety.

Conditions

Idiopathic Short Stature

Keywords

growth hormone

Outcome Measures

Primary Outcomes (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.

  26 weeks

Secondary Outcomes (1)

• Changes in Height Standard Deviation Score After 26 Weeks

  26 weeks

Other Outcomes (1)

• Changes in Anti-growth Hormone Antibody

  baseline and 26 weeks

Study Arms (2)

DA-3002 Treatment group

EXPERIMENTAL

1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)

Drug: DA-3002

Non-treatment control group

NO INTERVENTION

Height be measured with no treatment

Interventions

DA-3002 DRUG

Also known as: Recombinant Human Growth Hormone

DA-3002 Treatment group

Eligibility Criteria

• Age: 4 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Chronological Age ≥ 4
• Bone Age \<11 (for girls) and \<13 (for boys)
• Height \<3rd percentile for age
• normal thyroid function

You may not qualify if:

• endocrine and/or metabolic disorders
• growth failure caused by other disorders
• previous use of drugs that could interfere with Growth Hormone treatment

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

MeSH Terms

Interventions

Growth Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Hanwook Yoo
• Organization: Asan Medical Center

hwyoo@amc.seoul.kr

82-2-3010-3374

Study Officials

• Hanwook Yoo, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Byungkyu Suh, MD

  Seoul St. Mary's Hospital

  STUDY DIRECTOR

• Cheolwoo Ko, MD

  Kyungpook National University Hospital

  STUDY DIRECTOR

• Keehyoung Lee, MD

  Korea University Anam Hospitial

  STUDY DIRECTOR

• Dongkyu Jin, MD

  Samsung Medical Center

  STUDY DIRECTOR

• Choongho Shin, MD

  Seoul National University Hospital

  STUDY DIRECTOR

• Jinsoon Hwang, MD

  Aju University Hospital

  STUDY DIRECTOR

• Hoseong Kim, MD

  Severance Children's Hospital Yonsei University

  STUDY DIRECTOR

• Wooyoung Jeong, MD

  Pusan University Hospital

  STUDY DIRECTOR

• Chanjong Kim, MD

  Chonnam National University Hospital

  STUDY DIRECTOR

• Heonsuk Han, MD

  Chungbuk National University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: February 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 19, 2017
• Results First Posted: May 29, 2015

Record last verified: 2017-09