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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03274973
Recruitment Status : Terminated (Insufficient, delayed recruitment of participants)
First Posted : September 7, 2017
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Growth Disorders Drug: Zomacton

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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 : October 31, 2018
Actual Study Completion Date : October 31, 2018


Group/Cohort Intervention/treatment
Zomacton Drug: Zomacton
Injection




Primary Outcome Measures :
  1. Linear growth (change in height) [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric outpatient clinic
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274973


Locations
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Germany
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
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Study Director: Global Clinical Compliance Ferring Pharmaceuticals
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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03274973    
Other Study ID Numbers: 000302
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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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:
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Turner Syndrome
Gonadal Dysgenesis
Growth Disorders
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Pathologic Processes