International Cooperative Growth Study Post Marketing Surveillance Program For Nutropin Aq® [Somatropin (rDNA Origin) Injection] (iNCGS)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective and restrospective observational study, Post-marketing surveillance study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  SOMATROPIN
• Medical condition to be studied:
  Growth hormone deficiency

Population studied

• Short description of the study population:
  Boys and girls being treated with NutropinAq® for paediatric growth disorders for which growth hormone (GH) is indicated.; ; Patients must meet the following criteria to be eligible for study admission:; 1. Children of either sex who are initiating therapy or currently receiving therapy with NutropinAq® for the treatment of growth failure,; 2. Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable, and by the child when applicable,; 3. Patients who are willing to comply with follow-up appointments throughout study participation.
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Estimated number of subjects:
  3660

Study design details

• Main study objective:
  The objective of this non-interventional study is to collect long term safety and efficacy information on Ipsen's growth hormone (GH) NutropinAq® regarding treatment of paediatric growth disorders for which Growth Hormone is indicated.
• Data analysis plan:
  • Height, BMI and Weight SDS computation • Height velocity computation• Descriptive statistics for baseline demographics variables, disease history and aetiology, treatment compliance, Nutropin administration, growth hormone previous treatment, medical history and adverse events• Auxological data summary and change from baseline in auxological data• Analyses will be performed by etiology and by country

Documents

Study results

2-79-58035-005-synopsis_No redactions