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

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

Sponsors

Lead Sponsor: Ferring Pharmaceuticals

Source 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.

Overall Status Terminated
Start Date May 14, 2018
Completion Date October 31, 2018
Primary Completion Date October 31, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
Linear growth (change in height) Over the first 12 months (month 0, 3, 6, 9 and 12)
Enrollment 4
Condition
Intervention

Intervention Type: Drug

Intervention Name: Zomacton

Description: Injection

Arm Group Label: Zomacton

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Compliance Study Director Ferring Pharmaceuticals
Location
Facility: Klinik fuer Allgemeine Paediatrie der Christian-Albrechts-Universitaet zu Kiel (there might be other sites in this country)
Location Countries

Germany

Verification Date

December 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Zomacton

Acronym RAZANT
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov