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Enrolling by Invitation

NCT Number: 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

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.

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Key information

Conditions

Growth Hormone Deficiency in Children

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asai Clinic_Pediatrics, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somapacitan

Drug

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

Other names: Sogroya®

Primary outcomes

  1. Number of adverse reactions (AR)

    Time frame: From baseline (week 0) to end of study (up to 156 weeks)

    Measured as count of reactions.

Secondary outcomes

  1. Number of adverse events (AEs)

    Time frame: From baseline (week 0) to end of study (up to 156 weeks)

    Measured as count of events.

  2. Number of serious adverse events (SAEs)

    Time frame: From baseline (week 0) to end of study (up to 156 weeks)

    Measured as count of events.

  3. Number of serious adverse reactions (SARs)

    Time frame: From baseline (week 0) to end of study (up to 156 weeks)

    Measured as count of reactions.

  4. Change in height velocity (HV)

    Time frame: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)

    Measured in centimeter (cm)/year.

  5. Change in bone age

    Time frame: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)

    Measured in years.

  6. 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)

  7. Change in height standard deviation score (HSDS)

    Time frame: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)

  8. 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)

  9. 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)

    Measured as score ranging from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome.

  10. Growth hormone device assessment tool (G-DAT)

    Time frame: At 12 weeks

    Measured as count of patients choosing the individual response category. G-DAT is a questionnaire to gather information on how they feel about the GH product device assessed as "very easy", "easy", "neither difficult or easy", "difficult" or "very difficult" where "very easy" is best and "very difficult" is worst.

  11. Growth hormone patient preference questionnaire (GH-PPQ)

    Time frame: At 12 weeks

    Measured as count of patients choosing the individual response category. GH-PPQ is a disease specific questionnaire which measures the patient's growth hormone treatment preference.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 31, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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