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Clinical Trials/CTIS2022-501055-87-01
CTIS2022-501055-87-01
Active, not recruiting
Phase 1

A study evaluating the safety and efficacy of once-weekly dosing of somapacitan in a basket study design in paediatric participants with short stature either born small of gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature - NN8640-4469

ovo Nordisk A/S0 sites44 target enrollmentDecember 2, 2022
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ovo Nordisk A/S
Enrollment
44
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 2, 2022
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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