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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03274973 |
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Date of registration:
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29/08/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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 |
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Scientific title:
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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 |
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Date of first enrolment:
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May 14, 2018 |
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Target sample size:
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4 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03274973 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Global Clinical Compliance |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ferring Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Disorders
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Intervention(s)
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Drug: Zomacton
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Primary Outcome(s)
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Linear growth (change in height)
[Time Frame: Over the first 12 months (month 0, 3, 6, 9 and 12)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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