BridgeMD
A research study looking at how safe somapacitan is and how well it works in children who need help to grow – REAL 9
EU CTIS ID: 2022-501055-87-01
What this study is testing
To evaluate the safety of once-weekly somapacitan in children, either naïve or non-naïve to GH treatment, within each of the four indications: SGA, TS, NS or ISS.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Applicable to children with SGA - Born small for gestational age (according to national standards).
- Applicable to children with TS - Female participants: Age equal to or above xx years and below xx years at screening.
- Applicable to children with TS - Open epiphyses; defined as bone age xx years for females and bone age xx years for males.
- Applicable to children with NS - Diagnosis of NS according to local clinical practice.
- Applicable to children with NS - Male participants: Age equal to or above xx years and below xx years at screening. Female participants: Age equal to or above xx years and below xx years at screening.
- Applicable to children with NS - Open epiphyses; defined as bone age xx years for females and bone age xx years for males.
You likely can't join if
- Children with suspected or confirmed growth hormone deficiency according to local practice.
- Children diagnosed with diabetes mellitus or screening values from the central laboratory of fasting plasma glucose above or equal to xx
- Current inflammatory diseases requiring xx treatment for longer than xx
See the full eligibility criteria
- Applicable to children with SGA - Born small for gestational age (according to national standards).
- Applicable to children with TS - Female participants: Age equal to or above xx years and below xx years at screening.
- Applicable to children with TS - Open epiphyses; defined as bone age xx years for females and bone age xx years for males.
- Applicable to children with NS - Diagnosis of NS according to local clinical practice.
- Applicable to children with NS - Male participants: Age equal to or above xx years and below xx years at screening. Female participants: Age equal to or above xx years and below xx years at screening.
- Applicable to children with NS - Open epiphyses; defined as bone age xx years for females and bone age xx years for males.
- Applicable to children with ISS - Male participants: Age equal to or above xx years and below xx years at screening. Female participants: Age equal to or above xx years and below xx years at screening.
- Applicable to children with ISS - Open epiphyses; defined as bone age xx years for females and bone age xx years for males.
- Applicable to children with SGA - Male participants: Age equal to or above xx years and below xx years at screening. Female participants: Age equal to or above xx years and below xx years at screening.
- Applicable to children with SGA - Open epiphyses; defined as bone age xx years for females and bone age xx years for males.
- Applicable to children with TS - Diagnosis of TS according to local clinical practice.
- Children with suspected or confirmed growth hormone deficiency according to local practice.
- Children diagnosed with diabetes mellitus or screening values from the central laboratory of fasting plasma glucose above or equal to xx
- Current inflammatory diseases requiring xx treatment for longer than xx
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Malaysia
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Malaysia; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.