Saizen® E-Device User Trial
Condition: Growth Disorders
MeSH terms: Growth Disorders
Intervention: Saizen® E-Device
Intervention description: Saizen® (recombinant human growth hormone [r-hGH]) injection 8 milligram (mg) per 137 milliliter (mL) will be administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Keywords: Growth disorders

Summary:

      The aim of the study is to evaluate the E-Device performances and handling on the use in
      common practice, by collecting the impressions of patients, nurses and the investigator on
      the graphic interface, the instructions manual, the E-Device training and the material
      itself.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients naïve to, or experienced with, Saizen® with growth disorders in registered
             indications (GHD, Turner's Syndrome, Chronic Renal Failure, patient born Small
             Gestational Age [SGA] according to the local SmPC)

          2. Written informed consent must be obtained from the parent(s)/legal guardian(s) at the
             beginning of the study. Children able to understand the trial should personally sign
             and date the written informed consent

        Exclusion Criteria:

          1. Known hypersensitivity to somatropin or any of the excipients

          2. Epiphyseal fusion

          3. Active neoplasia (either newly diagnosed or recurrent)

          4. History of intracranial hypertension with papilledema

          5. Diabetes mellitus or history of significant glucose intolerance as defined by a
             fasting blood glucose > 116 mg/dL

          6. Severe congenital malformations

          7. Severe psychomotor retardation

          8. Known hepatic disease as defined by elevated liver enzymes or total bilirubin (x 2 N)

          9. Current congestive heart failure, untreated hypertension, serious chronic oedema of
             any cause

         10. Chronic infectious disease

         11. Previous or ongoing treatment with sex steroid therapy such as estrogens and
             testosterone

         12. Previous or ongoing treatment with any therapy that may directly influence growth,
             including GH, GHRF and long duration corticosteroids therapy

         13. Proliferative or preproliferative diabetic retinopathy

         14. Evidence of any progression or recurrence of an underlying intra-cranial space
             occupying lesion

         15. Precocious puberty

         16. Severe associated pathology affecting growth such as malnutrition, malabsorption or
             bone dysplasia

         17. Concomitant corticoid treatment or levothyroxine treatment other than substitutive
             treatment, topical or inhaled treatment

         18. Participation to any clinical study within the 30 days preceding study entry

         19. Pregnancy