Status:
COMPLETED
Post Marketing Surveillance on Long-term Use With Norditropin® (Short Stature Due to Noonan Syndrome)
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Genetic Disorder
Noonan Syndrome
Eligibility:
All Genders
3+ years
Brief Summary
The purpose of this study is to collect information about safety and effectiveness for long term use of Norditropin®. Participants will attend the medical institution according to usual practice and r...
Eligibility Criteria
Inclusion
- Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- The decision to initiate treatment with commercially available Norditropin® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
- For non-naïve patients; patients who were previously enrolled in study: GHLIQUID-4020.
- For naïve patients; short stature due to Noonan syndrome diagnosed by the physician and a decision to initiate treatment with Norditropin® has been made by the patient/parent and the physician. At study sites, all patients will be registered consecutively from the first patient after approval date (consecutively registered system).
- Male or female, 3 years old or over, bone age: less than 17 years old for male / less than 15 years old for female.
Exclusion
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Known or suspected allergy to study products or related products.
- In case of naïve patients, patients who have received growth hormone (GH) products for treatment of indication other than short stature due to Noonan syndrome before approval date of Noonan indication.
Key Trial Info
Start Date :
February 26 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 18 2022
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT03435627
Start Date
February 26 2018
End Date
January 18 2022
Last Update
November 14 2022
Active Locations (22)
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1
Novo Nordisk Investigational Site
Asahikawa, Hokkaido, Japan, 078-8510
2
Novo Nordisk Investigational Site
Fukuoka, Japan, 830-0011
3
Novo Nordisk Investigational Site
Kanagawa, Japan, 216-8511
4
Novo Nordisk Investigational Site
Kanagawa, Japan, 232-8555