Prader-Willi syndrome MedDRA version: 9.1 Level: LLT Classification code 10036476 Term: Prader-Willi syndrome
Conditions
Interventions
Trade Name: Humatrope 6 mg/12 mg/24 mg injektiokuiva-aine ja liuotin, liuosta varten
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12
Sponsors
Oy Eli Lilly Finland Ab
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if they meet all of the following criteria: [1] Patients received growth hormone therapy in Study B9R-HL-GDDV and completed the study [2]Patients must have given informed consent for Study B9R-HL-GDGN Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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 will be excluded from the study if they meet any of the following criteria: [3] Patients who cannot be contacted or are unable to return to the study site for visit for any other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to obtain adult height measurement on all 20 subjects with PWS who participated in the one year trial (B9R-HL-GDDV) of GH treatment in 1997 – 1999. In patients who have achieved their final height, the result will be compared to the predicted adult heights from the previous study (before starting GH and at one year). ;Secondary Objective: The secondary objectives of this study are • body composition (fat vs. fat-free tissue) assessed by DEXA • total weight • quality of life assessed by the 16D questionnaire • to collect safety information from all patients who participated in study B9R-HL-GDDV, including, but not restricted to - clinically significant adverse events that have been associated with growth hormone exposure as well as other events deemed clinically significant - symptoms referring to potential sleep apnea (e.g. snoring) - sleep polygraphy - phosphate levels ;Primary end point(s): N/A. | — |
Countries
Finland
Outcome results
None listed