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Enrolling by invitation NCT06109935

Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed

— Observational Growth Hormone Deficiency in Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Somapacitan.
Who it may be relevant to
Registry conditions: Growth Hormone Deficiency in Children. Basic parameters: 0 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Multi-centre, Prospective, Open Label, Single-arm, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Treatment in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed Under Normal Clinical Practice Conditions in Japan Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency (GHD) Where Epiphysial Discs Are Not Closed

Overview

The purpose of the study is to investigate the safety and effectiveness of Sogroya® in children with short stature due to growth hormone deficiency where epiphysial discs are not closed under real-world clinical practice in Japan. The study will last for about 1 year (at shortest) to 3 years (at longest) depending on when the participant takes part in the study. The participant will be asked to answer questionnaire(s) about how they feel about the growth hormone (GH) product treatment once during the study (at about 3 months after starting the Sogroya® treatment) and about 3 months after starting the Sogroya® treatment.

Interventions

  • Drug Somapacitan
    Sogroya® treatment regimen will be in accordance with the approved product labelling in Japan.

Primary outcome measures

  • Number of adverse reactions (AR) [Time frame: From baseline (week 0) to end of study (up to 156 weeks)]
Secondary outcome measures (11)
  • Number of adverse events (AEs) [Time frame: From baseline (week 0) to end of study (up to 156 weeks)]
  • Number of serious adverse events (SAEs) [Time frame: From baseline (week 0) to end of study (up to 156 weeks)]
  • Number of serious adverse reactions (SARs) [Time frame: From baseline (week 0) to end of study (up to 156 weeks)]
  • Change in height velocity (HV) [Time frame: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)]
  • Change in bone age [Time frame: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)]
  • Change in ratio of bone age/chronological age [Time frame: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)]
  • Change in height standard deviation score (HSDS) [Time frame: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)]
  • Change in height velocity standard deviation score (HVSDS) [Time frame: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)]
  • Change in insulin-like growth factor-I standard deviation score (IGF-I SDS) [Time frame: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)]
  • Growth hormone device assessment tool (G-DAT) [Time frame: At 12 weeks]
  • Growth hormone patient preference questionnaire (GH-PPQ) [Time frame: At 12 weeks]

Eligibility criteria

Inclusion criteria

  • Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  • The decision to initiate treatment with commercially available Sogroya® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study. Both GH treatment naïve and non-naïve children are eligible.
  • Male or female age 0 to 18 years (exclusive) at the time of signing informed consent.
  • Diagnosis with short stature due to GHD where epiphysial discs are not closed according to local normal clinical practice.

Exclusion criteria

  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Treatment with any investigational drug within 30 days prior to baseline (the starting date of Sogroya® treatment).
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  • Contraindication described in approved product labelling in Japan.
  • Patients with hypersensitivity to the active substance or to any of the excipients
  • Patients with malignant tumour
  • Female patients who are either pregnant or likely to be pregnant

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Japan · 86 centers
  • Hoshigaoka Seicho Clinic_Pediatrics — Aichi
  • Iwayama Pediatric_Pediatrics — Aichi
  • Asai Clinic_Pediatrics — Aichi
  • Mutsu general hospital_Pediatrics — Aomori
  • Asahikawa Medical Univ. Hospital_Pediatrics — Asahikawa, Hokkaido
  • Beppu Medical Center — Beppu-shi, Oita-ken
  • Inomata Child Clinic_Pediatrics — Chiba
  • Seirei Sakura Citizen Hospital_Pediatrics — Chiba
  • … and 78 more centers

Identifiers

NCT: NCT06109935 · NN8640-5005 · U1111-1274-4223

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗