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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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25 March 2024 |
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Main ID: |
NCT03972345 |
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Date of registration:
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31/05/2019 |
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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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Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
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Scientific title:
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A Non-interventional, Prospective Study in Germany to Investigate the Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in a Patient Population With Isolated Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA) |
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Date of first enrolment:
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June 21, 2019 |
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Target sample size:
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750 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03972345 |
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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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Clinical Transparency (dept. 2834) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Informed consent of parent or legally acceptable representative of subject and child
assent, as age-appropriate must be obtained before any study-related activities.
1. The parent or legally acceptable representative of the child must sign and date
the Informed Consent Form (according to local requirements) and
2. The child must sign and date the Child Assent Form or provide oral assent (if
required according to local requirements).
- The decision to initiate treatment with commercially available Norditropin® FlexPro®
has been made by the treating physician and the patient's parents/legal guardian
before and independently of the decision to include the patient in this study.
- Male or female, all age groups equal to or below 15 years with more than 2 years
expected remaining treatment time until reaching NFH. Patients who self-inject should
be above 8 years of age in order to be able to fill in the questionnaire.
- Children being GH naïve at baseline with one of the following confirmed diagnoses
1. Isolated growth hormone deficiency (iGHD)
2. Small for gestational age (SGA)
Exclusion Criteria:
- Previous participation in this study. Participation is defined as having given
informed consent in this study.
- Mental incapacity, unwillingness or language barriers precluding adequate
understanding or cooperation.
- Patients who have an expected future duration of therapy of less than 2 years are not
eligible for the study.
Age minimum:
0 Years
Age maximum:
15 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency in Children
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Born Small for Gestational Age
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Intervention(s)
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Drug: Norditropin® FlexPro®
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Primary Outcome(s)
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Near final height (NFH) standard deviation score (SDS) measured in scores
[Time Frame: At the end of the study (up to 10 years)]
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Secondary Outcome(s)
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Adherence response as indicated in question at the bottom of newly developed Patient Reported Outcome (PRO) questionnaire each time questionnaire is filled out (preferably at each visit)
[Time Frame: From baseline (month 0) to end of study (up to 10 years)]
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Change in growth rate (height velocity standard deviation score, HV SDS)
[Time Frame: From baseline (month 0) to end of study (up to 10 years)]
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Change of self-rated adherence level throughout the study measured in newly developed PRO questionnaire each time questionnaire is filled out (preferably at each visit)
[Time Frame: From baseline (month 0) to end of study (up to 10 years)]
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Adherence measured as number of medication devices returned versus number of prescribed devices for the period between visits
[Time Frame: From baseline (month 0) to end of study (up to 10 years)]
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Change in growth rate (HV SDS) between visits (usually patients are seen every 3 to 6 months)
[Time Frame: From baseline (month 0) to end of study (up to 10 years)]
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Secondary ID(s)
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GH-4488
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U1111-1217-5835
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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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