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.

• Register: EUCTR
• Last refreshed on: 4 August 2015
• Main ID: EUCTR2015-002802-34-Outside-EU/EEA
• Date of registration: 03/07/2015
• Prospective Registration: Yes
• Primary sponsor: Sandoz SAS
• Public title: 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.
• Scientific title: Multicentre study to evaluate the efficacy and safety of a liquid formulation of recombinant growth hormone, Omnitrope® 3.3mg/mL, in the treatment of pre-pubertal children of small stature suffering from somatotropin deficiency (GH) – phase IIIb
• Target sample size: 100
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002802-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

France

Contacts

• Name: Head Strategic Planning, BCD
• Affiliation: Hexal AG (a Sandoz company)

• Name: Head Strategic Planning, BCD
• Affiliation: Hexal AG (a Sandoz company)

Key inclusion & exclusion criteria

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Small stature secondary to growth hormone insufficiency deficiency

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Intervention(s)

Trade Name: Omnitrope
Pharmaceutical Form:

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. Over 12 months
2. Every 6 months

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

Primary end point(s): 1. Increase in growth rate over 12 month
2. Increase in levels of IGF-1 levels and growth hormone dependent markers (Acid-Labile Subunit (ALS), IGFBP-3)

Secondary Objective: Tolerance and acceptability

Secondary Outcome(s)

Secondary end point(s): 1. Local tolerance at injection site and in general
2. Acceptability of injection pen and tolerance of injections
3. Systemic tolerance by laboratory test results and adverse events
4. Immunologic tolerance by assessing the formation of anti-growth-hormone antibodies

Timepoint(s) of evaluation of this end point: 1. At each visit
2. After 12 months
3. Every 6 months
4. At inclusion and after 6 and 12 months

Secondary ID(s)

Sandoz/OMNI/F/01/03

Source(s) of Monetary Support

Sandoz SAS