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)

Launched by NOVO NORDISK A/S · May 31, 2019

Keywords

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Gender

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Eligibility criteria

• 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.