4263 - REAL4 somapacitan vs norditropin in children with GHD
Research type
Research Study
Full title
A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency
IRAS ID
258913
Contact name
Joanne Blair
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2018-000231-27
Duration of Study in the UK
5 years, 0 months, 21 days
Research summary
Some short children are treated with growth hormone injections. At present, injections need to be given every day, but we think a new form of this medication could be given once a week. In this study we will see if children treated with the injection given once a week grow as well as children treated with the injection given every day.
Participants will be allocated treatment with the daily injection (Norditropin) or the new medication (somapacitan) randomly. This means that neither the participant, their parent or doctor can chose which injection they receive. Twice as many participants will be treated with somapacitan as Norditropin. The participants will be treated with either Norditropin or somapacitan for one year, and then all participants will be treated with somapacitan for a further three years.
During the first year of the study, participants will be seen every three months after the initial information, screening, randomisation and 1 month visit have been completed. Over the entire study there will be 20 visits. Participants will be weighed and measured at each visit. The stage of puberty will be assessed along with a physical exam performed twice a year. Any change in health or new medications will be recorded. At the start of the study an ECG (heart tracing) will be performed, and a scan of the pituitary gland, which produces growth hormone, will be performed if this has not been performed within the last 9 months. A blood sample will be collected on visits 1, 3,4, 5, 6, 7, 9, 11, 13, 15, 17 and 19 and an x-ray of the hand and wrist will be obtained at the start of the study and then once a year.
To determine whether or not treatment with somapacitan is as effective as treatment with Norditropin, we will compare how fast participants treated with Norditropin grow to those treated with somapacitan.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
19/SC/0124
Date of REC Opinion
30 May 2019
REC opinion
Further Information Favourable Opinion