Comparing CinnaTropin® with Norditropin® NordiLet® in pre-pubertal children with growth hormone deficiency

Phase 3

Recruiting

• Conditions: Isolated idiopathic growth hormone deficiency.; Hypopituitarism

• Registration Number: IRCT20150303021315N12
• Lead Sponsor: CinnaGen company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 23 April 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

GH-naïve
Prepubertal (Tanner stage I)
3 to 10 years of age for male children and 3 to 8 years of age for female children
Isolated idiopathic growth hormone deficiency diagnosed
Peak growth hormone value of <10.0 µg/l following two recommended growth hormone stimulation tests
Height Standard Deviation Score (HSDS) = -2.0 and Height Velocity Standard Deviation Score (HVSDS) =-1.0; or HSDS = -3.0
The ratio of bone age to chronological age < 0.9
Full-term birth weight above 2500 g
Euthyroid state

Exclusion Criteria

Chronic systemic disease, such as diabetes mellitus or renal disease
Evidence of active tumor
Chromosomal or skeletal abnormalities
Signs of idiopathic intracranial hypertension
Closed epiphyses
Chronic use of oral or parenteral glucocorticoid in the past three months
Using methylphenidate in the last 14 days

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in height velocity. Timepoint: Prior to intervention and 12 months after the first intervention. Method of measurement: wall-mounted stadiometer.

Secondary Outcome Measures

Name	Time	Method
Change in height. Timepoint: Prior to intervention and 12 months after the first intervention. Method of measurement: wall-mounted stadiometer.;Change in weight. Timepoint: Prior to intervention and 12 months after the first intervention. Method of measurement: Weight measuring device.;Change in Height Standard Deviation Score (HSDS). Timepoint: Prior to intervention and 12 months after the first intervention. Method of measurement: Centers for Disease Control and Prevention clinical growth data.;Safety. Timepoint: At screening visit, first intervention, and 3, 6, 9, and 12 months after the first intervention. Method of measurement: Patient’s history, physical examination, and laboratory data.;Immunogenicity. Timepoint: Prior to first intervention and at 3, 6, 9, and 12 months after the first intervention. Method of measurement: Evaluation of the presence and titre of anti-drug antibody in the blood sample.