Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner Syndrome

Growth Disorders Clinical Trial

— RAZANT  

Official title:

A Prospective Non-Interventional Study to Assess Long-term Effectiveness of Zomacton® and Factors Affecting Adherence in Patients With Growth Hormone Deficiency or Growth Retardation Due to Ullrich-Turner Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03274973
• Other study ID #: 000302
• Status: Terminated
• Start date: May 14, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: December 2018
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Gonadal Dysgenesis
• Growth Disorders
• Primary Ovarian Insufficiency
• Turner Syndrome

Intervention

Drug:
• Zomacton
Injection

Locations

Country	Name	City	State
Germany	Klinik fuer Allgemeine Paediatrie der Christian-Albrechts-Universitaet zu Kiel (there might be other sites in this country)	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linear growth (change in height)	Change in height defined as the change of the standard deviation score of body height vs. baseline	Over the first 12 months (month 0, 3, 6, 9 and 12)