A study conducted at several study sites with a human growth hormone in a liquid form and a concentration of 3.3. mg/mL that is produced by using genetic engineering techniques, to find out more about how efficacious it works and how safe its use is in pre-pubertal children of small stature who’s bodies do not produce sufficient amounts of own growth hormone.

Conditions: Small stature secondary to growth hormone insufficiency deficiency
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2015-002802-34-Outside-EU/EEA

Lead Sponsor: Sandoz SAS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 100

Inclusion Criteria

- Small stature due to growth hormone deficiency
• Age: girls of under 10 years of age and boys of under 12
• Height = -2 SD or < -1.5 SD with slow Growth Rate (GR < -1 SD or < 4 cm/year)
• Weight in line with statural age ± 2SD
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Prior or current treatment with GH
• Presence of an active tumour; a lapse of at least 12 months will be required since tumour treatment
• Current corticosteroid treatment other than substitution treatment or use of an inhaled corticosteroid
• Insulin-dependent diabetes (according to the WHO definition), or other chronic, severe disease
• Small stature for other reasons than growth hormone deficiency
• Peutz-Jeghers syndrome or a family history of colon cancer

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Tolerance and acceptability;Primary end point(s): 1. Increase in growth rate over 12 month<br>2. Increase in levels of IGF-1 levels and growth hormone dependent markers (Acid-Labile Subunit (ALS), IGFBP-3)<br>;Timepoint(s) of evaluation of this end point: 1. Over 12 months<br>2. Every 6 months<br>;Main Objective: Evaluate the efficacy and tolerance of Omnitrope® 3,3 mg/ml solution fo injection, administered at a dose of 0,23 mg/kg/s on a clinical, biological and immunological level

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Local tolerance at injection site and in general<br>2. Acceptability of injection pen and tolerance of injections<br>3. Systemic tolerance by laboratory test results and adverse events<br>4. Immunologic tolerance by assessing the formation of anti-growth-hormone antibodies<br>;Timepoint(s) of evaluation of this end point: 1. At each visit<br>2. After 12 months<br>3. Every 6 months<br>4. At inclusion and after 6 and 12 months<br>