ESTUDIO AUXOGROWTH - Estudio Exploratorio para la Utilización del Programa de Crecimiento AuxoLog en Pacientes con Déficit de Hormona de Crecimiento tratados con Hormona de Crecimiento Recombinante Biosimilar

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-series, Observational, retrospective

Study drug and medical condition

• Name of medicine:
  OMNITROPE
• Medical condition to be studied:
  Growth hormone deficiency

Population studied

• Short description of the study population:
  Patients with Growth hormone deficiency.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with Growth hormone deficiency
• Estimated number of subjects:
  30

Study design details

• Main study objective:
  Assess the increase in stature (height, standard deviation (SD) of height), growth rate (GR) and standard deviation of growth rate (SDGR) in GHD children treated with Omnitrope® for a minimum of two years.
• Outcomes:
  HeightStandard deviation (SD) of height,Growth rate (GR)Standard deviation of growth rate (SDGR), Identify the time of pubertal development
• Data analysis plan:
  Absolute frequencies will be reported as a summary (n) and relative frequencies as a percentage (%), 95% confidence intervals (CI) will be also given. The ‘normality’ of quantitative variables will be checked with the Kolmogorov-Smirnov test, normally distributed variables will be then summarised using the mean and standard deviation. In all analyses, a significance level below 0.05 was established (95% confidence).

Documents

Study results

CLINICAL STUDY REPORT SDZ Global

Study report

CONTRATO FINAL FIRMADO (PTE FIRMA RESTO DE PAGINAS IP)

Study, other information

Anexo 5.1 APROBACION DEL CEIC

ANEXO 5.2 APROBACION CEIC REF.

Anexo 5.3 CLASIFICACION AGENCIA

CONTRATO FINAL FIRMADO_H PUERTA DEL MAR