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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.

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-002802-34-Outside-EU/EEA
Enrollment
100
Registered
2015-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small stature secondary to growth hormone insufficiency deficiency

Interventions

Trade Name: Omnitrope Pharmaceutical Form:

Sponsors

Sandoz SAS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Secondary Objective: Tolerance and acceptability;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) ;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—

Secondary

MeasureTime frame
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—

Countries

France

Contacts

Public ContactHead Strategic Planning, BCD

Hexal AG (a Sandoz company)

004980244760

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026