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

Primary Purpose

Turner's Syndrome

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

DA-3002

Genotropin®

About this trial

This is an interventional treatment trial for Turner's Syndrome focused on measuring Turner's Syndrome, Short Stature, Dwarfism

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DA-3002

Genotropin®

Arm Description

0.14 IU (0.045-0.050mg)/kg/day of DA-3002 is injected for 52 weeks by changing injecting areas

0.14 IU (0.045-0.050mg)/kg/day of Genotropin is injected for 52 weeks by changing injecting areas

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in height standard deviation score after 52 weeks

Changes in bone maturation(changes in bone ages/changes in chronological age)

Changes in IGF-1

Changes in IGFBP-3

Full Information

NCT ID

NCT01813630

First Posted

March 15, 2013

Last Updated

July 24, 2018

Sponsor

Dong-A ST Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01813630

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

February 2013 (Actual)

Primary Completion Date

May 2018 (Actual)

Study Completion Date

May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Turner's Syndrome

Keywords

Turner's Syndrome, Short Stature, Dwarfism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DA-3002

Arm Type

Experimental

Arm Description

0.14 IU (0.045-0.050mg)/kg/day of DA-3002 is injected for 52 weeks by changing injecting areas

Arm Title

Genotropin®

Arm Type

Active Comparator

Arm Description

0.14 IU (0.045-0.050mg)/kg/day of Genotropin is injected for 52 weeks by changing injecting areas

Intervention Type

Drug

Intervention Name(s)

DA-3002

Intervention Type

Drug

Intervention Name(s)

Genotropin®

Primary Outcome Measure Information:

Title

Annualized height velocity(cm/year) after 52 weeks

Description

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

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Changes in height standard deviation score after 52 weeks

Time Frame

52 weeks

Title

Changes in bone maturation(changes in bone ages/changes in chronological age)

Time Frame

52 weeks

Title

Changes in IGF-1

Time Frame

52 weeks

Title

Changes in IGFBP-3

Time Frame

52 weeks

Other Pre-specified Outcome Measures:

Title

Changes in anti-growth hormone antibody

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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

Overall Study Officials: