Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner Syndrome
- Registration Number
- NCT03274973
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
Assessment of long-term effectiveness of ZOMACTON in treatment of Growth Hormone Deficiency or growth retardation due to Ullrich-Turner Syndrome and assessment of compliance and adherence, optionally with the aid of an electronic app or patient diary.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria
- Pediatric patients (< 18 years) with growth hormone deficiency or growth retardation due to Ullrich-Turner-Syndrome
- Patients already receiving or who have been prescribed Zomacton® de novo according to its German label; the decision to prescribe Zomacton® was made independently from participation and prior to enrollment in this study.
- Patient and their parents (or legal representatives) who are willing and able to provide signed informed consent for use of their personal data.
Exclusion Criteria
- Participation in an interventional clinical study within the last 30 days prior to baseline visit or during the follow-up period
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Zomacton Zomacton -
- Primary Outcome Measures
Name Time Method Linear growth (change in height) Over the first 12 months (month 0, 3, 6, 9 and 12) Change in height defined as the change of the standard deviation score of body height vs. baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Klinik fuer Allgemeine Paediatrie der Christian-Albrechts-Universitaet zu Kiel (there might be other sites in this country)
🇩🇪Kiel, Germany