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

• Sponsor: Ferring Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03274973
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Actual Duration (Months): 5.6
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Growth Disorders	Drug: Zomacton

Study Design

• Study Type: Observational
• Actual Enrollment: 4 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: May 14, 2018
• Actual Primary Completion Date: Oct 31, 2018
• Actual Study Completion Date: Oct 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Zomacton	Drug: Zomacton; Injection

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik fuer Allgemeine Paediatrie der Christian-Albrechts-Universitaet zu Kiel (there might be other sites in this country)	Kiel		Germany	24105

Sponsors and Collaborators

• Ferring Pharmaceuticals

Investigators

• Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ferring Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03274973
• Other Study ID Numbers: 000302
• First Posted: Sep 7, 2017
• Last Update Posted: Dec 13, 2018
• Last Verified: Dec 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Growth Disorders

Study Results

No Results Posted as of Dec 13, 2018