French Registry of Children Treated With Norditropin® for Short Stature Associated With Noonan Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

221 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-16

Study Completion Date

2028-03-17

Brief Summary

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This is a non-interventional registry of children treated with Norditropin® for short stature due to Noonan Syndrome (NS). This study aims to provide data on long-term growth evolution and safety of Norditropin® as well as Health Related Quality of Life (HRQoL) data. This registry will include the entirety of children treated with Norditropin® for short stature due to NS over the inclusion period. The decision to initiate treatment with commercially available Norditropin® is made by the patient/parents/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.

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Detailed Description

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Conditions

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Noonan Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Incident patients

Children initiated Norditropin® upon their inclusion in the study but independently from the decision to participate in this study

Norditropin

Intervention Type DRUG

Patients will be treated with commercially available Norditropin® according to routine clinical practice at the discretion of the treating physician.

Prevalent patients - finished growth upon inclusion

Children were already treated with Norditropin® before their inclusion in the study and finished their growth upon their inclusion. Data collected retrospectively from medical records

Norditropin

Intervention Type DRUG

Patients will be treated with commercially available Norditropin® according to routine clinical practice at the discretion of the treating physician.

Prevalent patients - not finished growth upon inclusion

Children were already treated with Norditropin® before their inclusion in the study and did not finish their growth upon inclusion. Data collected both retrospectively and prospectively

Norditropin

Intervention Type DRUG

Patients will be treated with commercially available Norditropin® according to routine clinical practice at the discretion of the treating physician.

Interventions

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Norditropin

Patients will be treated with commercially available Norditropin® according to routine clinical practice at the discretion of the treating physician.

Intervention Type DRUG

Other Intervention Names

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Somatropin

Eligibility Criteria

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Inclusion Criteria

* Patients with a clinical and/or genetic diagnosis of NS
* Patients who are treated with Norditropin® (already treated or initiating) and who are followed in a participating center
* The decision to initiate treatment with commercially available Norditropin® has been made by the patient/parents/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study

Exclusion Criteria

* Patients/Parents/LAR opposed to the collection and processing of their children's medical data
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Eligible Sex

ALL

Accepts Healthy Volunteers

No