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

NCTNCT06109935Other idNN8640-5005Other idU1111-1274-4223

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Enrolling by invitation
Phase: Phase not stated
Enrollment: 200 participants (estimated)
Sponsor: Novo Nordisk A/S · Industry
Design: Not stated
Countries: 1 country
Japan
Start: 4 Oct 2023
Primary completion: 31 Jul 2026 (estimated)
Completion: 31 Dec 2026 (estimated)
First posted: 31 Oct 2023
Last update posted: 29 Apr 2026
Conditions: Growth Hormone Deficiency in Children

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20232024202520262027

Ph –
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
NCT06109935
4 Oct 2023 to est. 31 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

SomapacitanDrug

Arms1

Other
Children with GHD
Participants will be treated with commercially available Sogroya® according to routine clinical practice at the discretion of the treating physician. Administration will be according to the approved product labelling. The decision to treat a participant with Sogroya® is made at the treating physician's discretion before and independently from the decision to include the patient in this study.

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of adverse reactions (AR)
Time frame · From baseline (week 0) to end of study (up to 156 weeks)
Registry description
Measured as count of reactions.

Secondary outcomes(11)

Number of adverse events (AEs)
Time frame · From baseline (week 0) to end of study (up to 156 weeks)
Registry description
Measured as count of events.
Number of serious adverse events (SAEs)
Time frame · From baseline (week 0) to end of study (up to 156 weeks)
Registry description
Measured as count of events.
Number of serious adverse reactions (SARs)
Time frame · From baseline (week 0) to end of study (up to 156 weeks)
Registry description
Measured as count of reactions.
Change in height velocity (HV)
Time frame · Every 12 months from baseline (week 0) to end of study (up to 156 weeks)
Registry description
Measured in centimeter (cm)/year.
Change in bone age
Time frame · Every 12 months from baseline (week 0) to end of study (up to 156 weeks)
Registry description
Measured in years.
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)
Registry description
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.
Growth hormone device assessment tool (G-DAT)
Time frame · At 12 weeks
Registry description
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.
Growth hormone patient preference questionnaire (GH-PPQ)
Time frame · At 12 weeks
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 0 Years up to 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. 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. 3. Male or female age 0 to 18 years (exclusive) at the time of signing informed consent. 4. Diagnosis with short stature due to GHD where epiphysial discs are not closed according to local normal clinical practice. Exclusion Criteria: 1. Previous participation in this study. Participation is defined as having given informed consent in this study. 2. Treatment with any investigational drug within 30 days prior to baseline (the starting date of Sogroya® treatment). 3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 4. Contraindication described in approved product labelling in Japan. 1. Patients with hypersensitivity to the active substance or to any of the excipients 2. Patients with malignant tumour 3. Female patients who are either pregnant or likely to be pregnant

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