Primary outcomeNumber· Baseline up to 1 year
Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1
| Group | Value (percentage of participants) |
|---|---|
| Somatropin | 3.7 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataA Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
NCTNCT02311894 (opens ClinicalTrials.gov in a new tab)Other idML29543
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 82 participants (actual)
- Sponsor
- Genentech, Inc. · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 31 Mar 2015
- Primary completion
- 8 Nov 2017
- Completion
- 8 Nov 2017
- First posted
- 9 Dec 2014 (estimated)
- Last update posted
- 8 Jan 2019
- Conditions
- Growth Hormone Deficiency
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2015201620172018
- Ph 4
A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
NCT0231189431 Mar 2015 to 8 Nov 2017
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a Phase IV, multicenter, open-label, single-arm study of somatropin (rDNA origin) (Nutropin AQ v1.1) in pre-pubertal children with growth hormone deficiency (GHD) naïve to prior recombinant human growth hormone (rhGH) treatment. The study is designed to characterize the immunogenicity profile of somatropin (rDNA origin) injection when administered daily subcutaneously for 12 months. The clinical impact of immunogenicity will also be assessed.
Interventions
- SomatropinDrug
Arms1
Experimental
Somatropin
Children will receive daily SC injections of somatropin at a dose of up to 0.043 milligrams per kilogram per day (mg/kg/day) for 1 year.
Primary outcomes1
Outcomes the sponsor listed as primary.
Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1
Time frame · Baseline up to 1 year
Registry description
Participants who were tested positive to anti-GH antibody after initiation of study treatment.
Secondary outcomes(5)
Percentage of Participants Who Exhibit Functional Growth Attenuation
Time frame · Baseline up to 1 year
Registry description
Growth attenuation is defined as initial growth response greater than pretreatment velocity followed by reduction in growth response to below the pretreatment velocity in the subsequent 6- to 12-month treatment period or reaching ≤ 2 cm per year.
Percentage of Participants With Neutralizing Antibodies
Time frame · Baseline up to 1 year
Registry description
Among participants who developed positive anti-GH antibody post-baseline, participants who were tested positive to neutralizing anti-GH antibody during study participation.
Annualized Growth Velocity at Months 6 and 12 (Change From Baseline)
Time frame · Months 6, 12
Registry description
Annualized growth velocity is defined as (height - baseline height) / (date of height assessment - date of baseline)\*365.25. Results are presented according to anti-GH antibody status (positive included all participants that were anti-GH antibody positive at least once post-baseline visit and anti-GH antibody negative population included all participants that were anti-GH antibody negative at all post-baseline visits).
Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline)
Time frame · Months 6, 12
Registry description
Height Standard Deviation Score (SDS) allows for the comparison of a participants height to that of others in the same age group. Therefore, the average height for that age group will have the SDS of 0. In this study, the starting Height SDS score was ≤ -1.5 (≤ 5th percentile). Results are presented according to anti-GH antibody status (positive included all participants that were anti-GH antibody positive at least once post-baseline visit and anti-GH antibody negative population included all participants that were anti-GH antibody negative at all post-baseline visits.
Percentage of Participants With Adverse Events
Time frame · Baseline up to 1 year
Registry description
Among participants who received at least one dose of study drug, those who reported at least one adverse event during study participation.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(5)
Secondary outcomeNumber· Baseline up to 1 year
Percentage of Participants Who Exhibit Functional Growth Attenuation
| Group | Value (percentage of participants) |
|---|---|
| Somatropin | 2.6 |
Secondary outcomeNumber· Baseline up to 1 year
Percentage of Participants With Neutralizing Antibodies
| Group | Value (percentage of participants) |
|---|---|
| Somatropin | 0 |
Secondary outcomeMean· Months 6, 12
Annualized Growth Velocity at Months 6 and 12 (Change From Baseline)
| Group | Value (cm/year) | Spread |
|---|---|---|
| Somatropin | 5.3 | 2.89 |
Secondary outcomeMean· Months 6, 12
Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline)
| Group | Value (SDS) | Spread |
|---|---|---|
| Somatropin | 0.3 | 0.11 |
Secondary outcomeNumber· Baseline up to 1 year
Percentage of Participants With Adverse Events
| Group | Value (percentage of participants) |
|---|---|
| Somatropin | 69.5 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| SomatropinChildren will receive daily subcutaneous (SC) injections of somatropin at a dose of up to 0.043 milligrams per kilogram per day (mg/kg/day) for 1 year. | 0 / 82 | 0 / 82 | 40 / 82 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 3 Years up to 14 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Bone age less than equal to (\</=) 9 years (females) or \</= 11 years (males) as determined by X-ray of the left hand and wrist using Greulich and Pyle method and obtained within the 12 months prior to enrollment
* Prepubertal (Tanner I) males and females by physical examination
* Diagnosis of GHD (stimulated GH less than \[\<\] 10 nanograms per milliliter \[ng/mL\]) by two standard pharmacologic tests obtained up to 12 months prior to informed consent/assent
* Normal thyroid function test within the 12 months prior to informed consent/assent
* Normal complete blood counts within 12 months prior to informed consent/assent
* Documentation of prior height and weight measurements, with height standard deviation score (SDS) \</= 5th percentile for idiopathic isolated GHD participants
Exclusion Criteria:
* Any previous rhGH treatment
* Short stature etiologies other than GHD
* Acute critical illness or uncontrolled chronic illness, which in the opinion of the investigator and medical monitor, would interfere with participation in this study, interpretation of the data, or pose a risk to participant safety
* Chronic illnesses such as inflammatory bowel disease, celiac disease, heart disease, and diabetes
* Bone diseases such as achondroplasia or hypochondroplasia, intracranial tumor, irradiation, and traumatic brain injury
* Participants receiving oral or inhaled chronic corticosteroid therapy (greater than \[\>\] 3 months) for other medical conditions other than central adrenal insufficiency
* Participants who require higher (2 times or greater than maintenance) doses of corticosteroids for more than 5 days in the 6 months prior to enrollment in the study
* Participants with active malignancy or any other condition that the investigator believes would pose a significant hazard to the participant if rhGH were initiated
* Females with Turner syndrome regardless of their GH status
* Prader-Willi syndrome regardless of GH status
* Born small for gestational age regardless of GH status
* Presence of scoliosis requiring monitoring
* Previous participation in another clinical trial or investigation of GH, treatment for growth failure, or treatment with a biologic agent
* Participants with closed epiphyses
* Participants with a known hypersensitivity to somatropin, excipients, or diluent
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