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Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years

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Novo Nordisk

Status and phase

Completed
Phase 3

Conditions

Small for Gestational Age
Foetal Growth Problem

Treatments

Drug: somatropin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00184691
GHRETARD-1106

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.

Enrollment

78 patients

Sex

All

Ages

2 to 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • IUGR defined as birth length and/or weight below the lower limit (< P10) of the Lubchenco curves for the gestational age.
  • Chronological age = 2-5 years
  • HV below average for CA
  • Insufficient catch-up growth (Height < P3 for chronological age, according to Hernández)
  • Parental height greater than or equal to -2 SDS of average, that is, 160 cm or more for the father and 148 cm or more for the mother
  • Normal response to GH stimulation test (greater tan or equal to 10 ng/mL)
  • Bone age (measured through Greulich and Pyle method) less than or equal to CA

Exclusion criteria

  • Children born from multiple pregnancy
  • Children with post-ischemic encephalopathy
  • Recorded malformative syndromes associated to short stature (Silver-Russell, Rubinstein Taybi, Seckel etc.)
  • Any metabolic or endocrinological disorder (diabetes mellitus, diabetes insipidus, congenital metabolic disorders, with the exception of thyroid diseases corrected by replacement therapy)
  • Any type of growth retardation associated to infections, embryopathies or severe chronic diseases (hemopathies, hepatopathies, malabsorptive pathology, neurologic alterations....)
  • Nutritional disorders (celiac disease) or osteodystrophies
  • Patients who receive or received any treatment (anabolic drugs, sex steroids, etc.) likely to interfere with GH effects
  • Abnormal karyotype
  • Neoplasms
  • Previous or ongoing chemotherapy and/or irradiation
  • Renal dysfunction, defined as serum creatinine > 1 mg/dL

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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