Short Stature
Conditions
Interventions
Trade Name: Humatrope
Product Name: Humatrope
Product Code: LY137998
Pharmaceutical Form: Injection*
INN or Proposed INN: Somatropinum
Current Sponsor code: LY137998
Concentration unit: mg milligram(
Sponsors
UAB “Eli Lilly Lietuva”
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Core programme: all patients treated with Humatrope for growth promotion DNA analysis sub-study: patients who fulfil the scoring criteria Growth prediction sub-study: therapy-naïve patients SHOX deficiency sub-study: patients with Turner syndrome, Léri-Weill or Langer syndrome (with or without SHOX defect), or other growth disorder with proven SHOX defect, treated or non-treated (control group) Neoplasia sub-study: patients with a history of neoplasia and endocrine or growth disorder, treated or non-treated (control group) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients treated long-term data on efficacy of GH treatment with other HGH
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Collect long-term safety and efficacy data on Humatrope in pediatrics;Secondary Objective: Develop new science (e.g. genetics of GHD, SHOX deficiency) Provide services to physicians and fill gaps (e.g. DNA analyses, growth prediction for dose adjustments, IGF measurements;Primary end point(s): To collect clinical, biochemical and genetic data To identify non-responders early To optimize dose for individual needs To monitor compliance To verify the diagnosis To identify additional problems (e.g. unregognized hypothyroidism) Long-term data on safety and efficacy of GH treatment | — |
Countries
Lithuania
Outcome results
None listed