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

D

Dong-A ST

Status and phase

Completed
Phase 3

Conditions

Infant, Small for Gestational Age

Treatments

Drug: DA-3002
Drug: Genotropin®

Study type

Interventional

Funder types

Industry

Identifiers

NCT02770157
DA3002_SGA_III

Details and patient eligibility

About

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

Enrollment

75 patients

Sex

All

Ages

4 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 3 patient groups

DA-3002
Experimental group
Description:
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).
Treatment:
Drug: DA-3002
Genotropin®
Active Comparator group
Description:
1.44 IU (0.48mg)/kg/week of Genotropin is injected for 52 weeks by changing injecting areas(six or seven times per week).
Treatment:
Drug: Genotropin®
Non-treatment control group
Other group
Description:
After 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).
Treatment:
Drug: DA-3002

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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