Small for Gestational Age (SGA), Idiopathic Short Stature (ISS)
Conditions
Interventions
Somatrogon (genetical recombination) is 0.85 mg/kg SC once a week.
Sponsors
Furukawa Yuichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of SGA or ISS. SGA, defined as born with a birth weight and/or length =3 years and =3 years and <11 years 3. Pre-pubertal- Tanner stage 1 for breasts and testes. 4. A bone age of not more than chronological age recorded in previous 8 weeks. 5. Current height < -2 SDS for age and gender. 6. Participants using hormonal replacement therapy(s) must be on an optimized and stable treatment regimen (hormone levels within normal ranges on screening) for at least three months prior to screening 7. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. History of cancer, radiation therapy or chemotherapy. 2. History of GHD. 3. Children who are small due to malnutrition, defined as a Z score of weight for height and/or BMI below -2 for age, according to national standards. 4. History of HIV-positive, acquired immune deficiency syndrome (AIDS), hepatitis B, hepatitis C, or tuberculosis. 5. Microcephaly (Head Circumference 2 SDS 10. Any disorder or condition which, in the opinion of the investigator, might jeopardize participant's safety or compliance with the protocol 11. Prior exposure to growth promoting therapy 12. Current use of any prohibited concomitant medication(s): Any rhGH or growth-promoting therapy, Any therapy that affects appetite or weight, Psychiatric medications associated with weight changes and/or diabetes, excluding medications used to treat ADHD, Any androgen or estrogen therapy including over the counter supplements, Systemic corticosteroids (inhaled or oral) exceeding the doses: Inhaled: > 400 microgram/day of inhaled budesonide or equivalent. Oral: > 8 mg/m2/day of oral hydrocortisone or equivalent. 13. Previous administration with an investigational drug within 90 days. 14. Fasting blood glucose >126 mg/dL 15. Renal impairment 16. Hepatic dysfunction. 17. Pregnancy 18. Known hypersensitivity to the components of the study intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized height velocity after 12 months of treatment | — |
Countries
Czech Republic, France, Greece, India, Israel, Japan, Poland, United States
Contacts
Public ContactYuichi Furukawa
Fortrea Japan K.K.
Outcome results
None listed