Growth Hormone DisorderPhase 2NCT00936403
A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone
A Phase 2 study testing NNC126-0083 and somatropin in people with Growth Hormone Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 21 sites in 10 countries.
Trial summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of a… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Growth Hormone Disorder, Growth Hormone Deficiency in Children
- What is being tested?
- NNC126-0083 and somatropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 21 sitesin 10 countries
- Study dates
- Aug 2009to Jul 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed diagnosis of growth hormone insufficiency as defined by two different GH provocation tests, defined as a peak of GH level less than 7ng/ml
- Pre-pubertal children
- Growth hormone replacement treatment for at least three months
Who cannot join
- Evidence of tumour growth or malignant disease
- Growth hormone deficient children with overt diabetes mellitus (fasting blood glucose more than 126mg/dl)
Trial locations and contacts
21 sites in 10 countries.
21 sites in 10 countries
Israel4 sites
Novo Nordisk Investigational Site
Beersheba, 84101
Novo Nordisk Investigational Site
Jerusalem, 91240
Novo Nordisk Investigational Site
Kfar Saba, 44281
Novo Nordisk Investigational Site
Petah Tikva, 49202
Spain4 sites
Novo Nordisk Investigational Site
Barcelona, 08035
Novo Nordisk Investigational Site
Esplugues Llobregat, 08950
Novo Nordisk Investigational Site
Santiago de Compostela, 15706
Novo Nordisk Investigational Site
Vitoria-Gasteiz, 01009
Turkey (Türkiye)3 sites
Novo Nordisk Investigational Site
Ankara, 06100
Novo Nordisk Investigational Site
Ankara
Novo Nordisk Investigational Site
Istanbul, 34093
Belgium2 sites
Novo Nordisk Investigational Site
Brussels, 1090
Novo Nordisk Investigational Site
Ghent, 9000
France2 sites
Novo Nordisk Investigational Site
Bron, 69677
Novo Nordisk Investigational Site
Toulouse, 31059
United Kingdom2 sites
Novo Nordisk Investigational Site
Birmingham, B4 6NH
Novo Nordisk Investigational Site
Cambridge, CB2 2QQ
About this study
Official title: A Randomised, Open-labelled, Single Dose, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin NordiFlex® in Growth Hormone Deficient Children
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083) in growth hormone deficient children.
- Being tested
- NNC126-0083, somatropin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC126-0083Drug
One single dose administered in four dose levels in an escalating order
somatropinDrug
A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant
| Study group | Role | What they receive |
|---|---|---|
| NNC126-0083 | Experimental | Not described Receives: Drug: NNC126-0083 |
| Norditropin NordiFlex® | Active comparator | Not described Receives: Drug: somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse events (AEs)
Measured: 0-10 days after dosing
Secondary outcomes (2)
AUC (0-168h), the area under the plasma NNC126-0083 profile in the interval 0-168 hours after trial product administration
Measured: Measured 10 days after dosing
IGF-I AUC (0-168h) the area under IGF-I profile in the interval 0-168 hours after trial product administration
Measured: Measured 10 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936403
- Sponsor's protocol ID
- NN8630-1824
- Other IDs
- 2008-008240-25, 2008
- Status last verified
- Feb 2017
- First submitted
- 9 Jul 2009
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
de Schepper J, Rasmussen MH, Gucev Z, Eliakim A, Battelino T. Long-acting pegylated human GH in children with GH deficiency: a single-dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics. Eur J Endocrinol. 2011 Sep;165(3):401-9. doi: 10.1530/EJE-11-0536. Epub 2011 Jul 1.
PubMed 21724838Papathanasiou T, Agerso H, Damholt BB, Hojby Rasmussen M, Kildemoes RJ. Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin(R) in Children and Adults. Clin Pharmacokinet. 2021 Sep;60(9):1217-1226. doi: 10.1007/s40262-021-01011-3. Epub 2021 Apr 17.
PubMed 33864240
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-labelled, Single Dose, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin NordiFlex® in Growth Hormone Deficient Children
- ClinicalTrials.gov ID
- NCT00936403
- Acronym / sponsor ID
- NN8630-1824
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083) in growth hormone deficient children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC126-0083 | Experimental | Drug: NNC126-0083 |
| Norditropin NordiFlex® | Active comparator | Drug: somatropin |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Confirmed diagnosis of growth hormone insufficiency as defined by two different GH provocation tests, defined as a peak of GH level less than 7ng/ml
- Pre-pubertal children
- Growth hormone replacement treatment for at least three months
Key exclusion criteria (2 listed)
- Evidence of tumour growth or malignant disease
- Growth hormone deficient children with overt diabetes mellitus (fasting blood glucose more than 126mg/dl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC126-0083One single dose administered in four dose levels in an escalating order | Drug | NNC126-0083 |
| somatropinA daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant | Drug | Norditropin NordiFlex® |
Primary outcome
Frequency of Adverse events (AEs)
Time frame: 0-10 days after dosing
2 secondary outcomes
AUC (0-168h), the area under the plasma NNC126-0083 profile in the interval 0-168 hours after trial product administration
Time frame: Measured 10 days after dosing
IGF-I AUC (0-168h) the area under IGF-I profile in the interval 0-168 hours after trial product administration
Time frame: Measured 10 days after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Results publication: PubMed 21724838de Schepper J, Rasmussen MH, Gucev Z, Eliakim A, Battelino T. Long-acting pegylated human GH in children with GH deficiency: a single-dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics. Eur J Endocrinol. 2011 Sep;165(3):401-9. doi: 10.1530/EJE-11-0536. Epub 2011 Jul 1.
- Derived from this study: PubMed 33864240Papathanasiou T, Agerso H, Damholt BB, Hojby Rasmussen M, Kildemoes RJ. Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin(R) in Children and Adults. Clin Pharmacokinet. 2021 Sep;60(9):1217-1226. doi: 10.1007/s40262-021-01011-3. Epub 2021 Apr 17.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Growth Hormone Disorder
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
RecruitingPhase 3
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
PIK3CA Mutation, HER2- Negative Breast Cancer
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
21 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NNC126-0083 and somatropin in people with Growth Hormone Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 21 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Israel, Spain, Turkey (Türkiye), Belgium, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse events (AEs) (time frame: 0-10 days after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00936403, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.