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

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)

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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