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)

Last updated: September 20, 2024
Sponsor: Novo Nordisk A/S
Overall Status: Active - Enrolling

Phase

N/A

Condition

Growth Hormone Deficiencies/abnormalities

Treatment

Norditropin® FlexPro®

Clinical Study ID

NCT03972345
GH-4488
U1111-1217-5835
  • Ages < 15
  • All Genders

Study Summary

Participants are free to decide if they want to take part in this study or not. The study will be conducted to collect information about the influence of adherence to growth hormone therapy with Norditropin® in children and teenagers in daily practice in Germany. This study will look mainly at the difference in near final height between children and teenagers who adhere to their therapy plan with Norditropin® to non-adherent patients. Participants will get Norditropin® as prescribed to them by their doctor. The study will last as long as the therapy with growth hormone is seen necessary by the participants' doctors and the participants, up to a maximum of 10 years. During the visits at the participants' doctors participants will be asked to fill in a questionnaire.

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.
  1. The parent or legally acceptable representative of the child must sign and datethe Informed Consent Form (according to local requirements) and

  2. 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

  1. Isolated growth hormone deficiency (iGHD)

  2. 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

Total Participants: 750
Treatment Group(s): 1
Primary Treatment: Norditropin® FlexPro®
Phase:
Study Start date:
June 21, 2019
Estimated Completion Date:
June 30, 2031

Connect with a study center

  • Novo Nordisk Investigational Site

    Ulm, 89075
    Germany

    Site Not Available

  • Universitätsklinikum Ulm für Kinder- und Jugendmedizin

    Ulm, 89075
    Germany

    Site Not Available

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