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)

Novo Nordisk

Status: Invitation-only

Conditions: Growth Hormone Deficiency in Children; Born Small for Gestational Age

Treatments: Drug: Norditropin® FlexPro®

Study type: Observational

Funder types: Industry

Identifiers

NCT03972345

GH-4488

U1111-1217-5835 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: Under 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

750 participants in 1 patient group

Paediatric patients with iGHD or SGA

Description:

Children with one of the following confirmed diagnoses: isolated growth hormone deficiency (iGHD) or small for gestational age (SGA)

Treatment:

Drug: Norditropin® FlexPro®