Phase
Condition
Growth Hormone Deficiencies/abnormalities
Treatment
Norditropin® FlexPro®
Clinical Study ID
Ages < 15 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Informed consent of parent or legally acceptable representative of subject and childassent, as age-appropriate must be obtained before any study-related activities.
The parent or legally acceptable representative of the child must sign and datethe Informed Consent Form (according to local requirements) and
The child must sign and date the Child Assent Form or provide oral assent (ifrequired 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 guardianbefore 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 yearsexpected remaining treatment time until reaching NFH. Patients who self-injectshould 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
Isolated growth hormone deficiency (iGHD)
Small for gestational age (SGA)
Exclusion
Exclusion Criteria:
Previous participation in this study. Participation is defined as having giveninformed consent in this study.
Mental incapacity, unwillingness or language barriers precluding adequateunderstanding or cooperation.
Patients who have an expected future duration of therapy of less than 2 years arenot eligible for the study.
Study Design
Connect with a study center
Novo Nordisk Investigational Site
Ulm, 89075
GermanySite Not Available
Universitätsklinikum Ulm für Kinder- und Jugendmedizin
Ulm, 89075
GermanySite Not Available
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