Treatment with recombinant Growth Hormone in Children born Small for Gestational Age (SGA) without Catch-up Growth. - Not applicable

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001507-19-IE

Enrollment

350

Registered

2005-04-07

Start date

2005-05-22

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

Short stature in children born small for gestational age without catch up growth

Interventions

Trade Name: Norditropin® SimpleXx® Product Name: Norditropin® SimpleXx® Product Code: Growth Hormone Pharmaceutical Form: Solution for injection INN or Proposed INN: Somatropin Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Small for gestational age (BW 1 SD below parental adjusted HSDS) •Age 4-8 years (girls) and 4-9 years (boys) •Pre-pubertal at start of treatment (testis volume =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Known or suspected allergy to growth hormone •Previous participation in growth hormone trial •Severe mental retardation as judged by the investigation •Previous or active malignancy •Benign intracranial hypertension (present or past) •Diabetes mellitus •Growth retardation due to chronic diseases including hypertension, asthma (if on inhaled corticosteroids >800µg/day), syndromes (like fetal alcohol syndrome) and chromosomal anomalies (except Silver Russell syndrome). •Psychological problems likely to lead to significant non-compliance.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate 1. Different growth hormone doses (low, high, and IGF-I titrated dose) on short and long term height velocity, final height and insulin sensitivity in short children (Height <-2.5SDS) born SGA (Birth weight <-2SDS). 2. Auxological, biochemical, and genetic predictors of growth response and insulin resistance in short SGA GH treated children. ;Secondary Objective: To evaluate long-term effects and safety of childhood GH treatment in SGA children as evaluated in adulthood (5 and 10 years after attainment of final height). ;Primary end point(s): Primary endpoints: Height gain ?SDS (3 year) Secondary endpoints: Insulin resistance (IVGTT) IGF-related parameters (IGF-1, IGFBP-3, ALS, free IGF-1) Genetic polymorphisms in the population (IGF-1, VNTR, GH receptor) Changes in body composition and BMD (DEXA) Final height	—

Measure

Time frame

Main Objective: To evaluate 1. Different growth hormone doses (low, high, and IGF-I titrated dose) on short and long term height velocity, final height and insulin sensitivity in short children (Height <-2.5SDS) born SGA (Birth weight <-2SDS). 2. Auxological, biochemical, and genetic predictors of growth response and insulin resistance in short SGA GH treated children. ;Secondary Objective: To evaluate long-term effects and safety of childhood GH treatment in SGA children as evaluated in adulthood (5 and 10 years after attainment of final height). ;Primary end point(s): Primary endpoints: Height gain ?SDS (3 year) Secondary endpoints: Insulin resistance (IVGTT) IGF-related parameters (IGF-1, IGFBP-3, ALS, free IGF-1) Genetic polymorphisms in the population (IGF-1, VNTR, GH receptor) Changes in body composition and BMD (DEXA) Final height

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Countries

Ireland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 19, 2026