An observational study in Genetic Disorder and Noonan Syndrome, sponsored by Novo Nordisk A/S. Completed at 22 sites in Japan. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2022-11-14.
Sponsored by Novo Nordisk A/S · Observational
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Among 23 studies in Genetic Diseases, Inborn by Novo Nordisk A/S — none open to participants now, 2 under way, 2 of them phase 3. Genetic Diseases, Inborn · Novo Nordisk A/S.
Among the 23 studies in Genetic Diseases, Inborn by Novo Nordisk A/S, this one is the only one that started in 2018, is one of 8 observational ones, and was the 19th registered.
583 studies on the registry are indexed under Genetic Diseases, Inborn; 157 are open to participants now.
Browse Genetic Diseases, Inborn studies →None of the 23 studies in Genetic Diseases, Inborn by Novo Nordisk A/S is open now. The open studies under Genetic Diseases, Inborn, anywhere →
Of the 120 Genetic Diseases, Inborn studies recruiting now, 60 (50%) set no upper age limit and 45 (38%) stop at 75 or younger; 85 take children under 18; 28 take healthy volunteers.
This study: 3 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
First in 1987; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 71 is below the median of 151 across 239 observational studies indexed under Genetic Diseases, Inborn.
Median enrollment 51 across the 15 interventional studies, 238 across the 8 observational. Of the 21 that completed or were terminated, 3 (14%) have results posted.
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Novo Nordisk A/S is the lead sponsor of 1,408 studies on the registry; 105 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 23 studies in Genetic Diseases, Inborn by Novo Nordisk A/S, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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 receive medical care, as agreed with the study doctor.
A total of 60 patients (consisting of non-naïve patients who were previously enrolled in study: GHLIQUID-4020 and naïve patients enrolled after approval of the Noonan indication in Japan) are planned to be included in this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The treatment period of Norditropin® for naïve participants will be up to 208 weeks.
Drug: Somatropin
The treatment period of Norditropin® for non-naïve participants will be up to 442 weeks.
Drug: Somatropin
Participants will be treated with commercially available Norditropin® (somatropin) according to routine clinical practice at the discretion of the treating physician.
Number of adverse drug reactions (ADR)
Count of events
Time frame: Weeks 0-208
Number of serious adverse drug reaction (SADR)
Count of events
Time frame: Week 0-208
Number of serious adverse event (SAE)
Count of events
Time frame: Week 0-208
Number of cardiac adverse event (AE)
Count of events
Time frame: Week 0-208
Change in insulin like growth factor I (IGF-I) for non-naïve patients
Measured in ng/mL
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in insulin like growth factor I (IGF-I) for naïve patients
Measured in ng/mL
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in insulin like growth factor I standard deviation score (IGF-I SDS) for non-naïve patients
Presented as standard deviation (SD) score
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in insulin like growth factor I standard deviation score (IGF-I SDS) for naïve patients
Presented as SD score
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in haemoglobin A1c (HbA1c) for non-naïve patients
Measured in %
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in haemoglobin A1c (HbA1c) for naïve patients
Measured in %
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in aspartate aminotransferase (AST) for non-naïve patients
Measured in IU/L
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in aspartate aminotransferase (AST) for naïve patients
Measured in IU/L
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in alanine aminotransferase (ALT) for non-naïve patients
Measured in IU/L
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in alanine aminotransferase (ALT) for naïve patients
Measured in IU/L
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in total cholesterol (T-CHO) for non-naïve patients
Measured in mg/dL
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in total cholesterol (T-CHO) for naïve patients
Measured in mg/dL
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in high-density lipoprotein cholesterol (HDL-C) for non-naïve patients
Measured in mg/dL
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in high-density lipoprotein cholesterol (HDL-C) for naïve patients
Measured in mg/dL
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in Low-density lipoprotein cholesterol (LDL-C) for non-naïve patients
Measured in mg/dL
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in Low-density lipoprotein cholesterol (LDL-C) for naïve patients
Measured in mg/dL
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in triglyceride (TG) for non-naïve patients
Measured in mg/dL
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in triglyceride (TG) for naïve patients
Measured in mg/dL
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in thyroid stimulation hormone(TSH) for non-naïve patients
Measured in μU/mL
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in thyroid stimulation hormone(TSH) for naïve patients
Measured in μU/mL
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in free triiodothyronine (FT-3) for non-naïve patients
Measured in pg/mL
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in free triiodothyronine (FT-3) for naïve patients
Measured in pg/mL
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in free thyroxine (FT-4) for non-naïve patients
Measured in ng/mL
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in free thyroxine (FT-4) for naïve patients
Measured in ng/mL
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in white blood cell (WBC) for non-naïve patients
Measured in μ/L
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in white blood cell (WBC) for naïve patients
Measured in μ/L
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in platelet (PLT) for non-naïve patients
Measured in 10\^4/μL
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in platelet (PLT) for naïve patients
Measured in 10\^4/μL
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in bone age (BA) for non-naïve patients
Measured in year
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in bone age (BA) for naïve patients
Measured in year
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in bone age/chronological age (BA/CA) for non-naïve patients
Presented as ratio
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in bone age/chronological age (BA/CA) for naïve patients
Presented as ratio
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in electrocardiogram (ECG) for non-naïve patients
Assessment of change in ECG is measured by categories recorded in case report forms (CRFs): normal, abnormal not clinically significant and abnormal clinically significant.
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in electrocardiogram (ECG) for naïve patients
Assessment of change in ECG is measured by categories recorded in CRFs: normal, abnormal not clinically significant and abnormal clinically significant.
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Change in height standard deviation score (HSDS) for non-naïve patients
Presented as SD score
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Change in height standard deviation score (HSDS) for naïve patients
Presented as SD score
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Height velocity standard deviation score (HVSDS) for non-naïve patients
Presented as SD score
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Height velocity standard deviation score (HVSDS) for naïve patients
Presented as SD score
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Height velocity (HV) for non-naïve patients
Measured in cm/year
Time frame: Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks
Height velocity (HV) for naïve patients
Measured in cm/year
Time frame: Weeks 0, 52, 104, 156, and 208 weeks
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Data sharing details ↗ · novonordisk-trials.com
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Jan 2022, 46 months.
Of 128 observational studies under Genetic Diseases, Inborn, half reached primary completion within 110 months of starting (the median), counting those still running; a quarter within 46 and three quarters within 193. This study's 46 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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