Trial · NCT02311894
A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
NCT02311894, Phase 4, Completed, Genentech, Inc.; results first posted 2018-11-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency. Trials, record NCT02311894. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02311894
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
- NCT number
- NCT02311894
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 82 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Growth Hormone Deficiency
- Interventions
- Somatropin
- First posted
- 2014-12-09
- Last updated
- 2019-01-08
- Results first posted
- 2018-11-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1 | Baseline up to 1 year | Participants who were tested positive to anti-GH antibody after initiation of study treatment. |
| Secondary | Percentage of Participants Who Exhibit Functional Growth Attenuation | Baseline up to 1 year | 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. |
| Secondary | Percentage of Participants With Neutralizing Antibodies | Baseline up to 1 year | Among participants who developed positive anti-GH antibody post-baseline, participants who were tested positive to neutralizing anti-GH antibody during study participation. |
| Secondary | Annualized Growth Velocity at Months 6 and 12 (Change From Baseline) | Months 6, 12 | 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). |
| Secondary | Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline) | Months 6, 12 | 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. |
| Secondary | Percentage of Participants With Adverse Events | Baseline up to 1 year | Among participants who received at least one dose of study drug, those who reported at least one adverse event during study participation. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1 | Baseline up to 1 year | All enrolled participants who received at least one dose of study drug and who had at least one post-baseline assessment | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Exhibit Functional Growth Attenuation | Baseline up to 1 year | All enrolled participants who received at least one dose of study drug and who had at least one post-baseline assessment | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Neutralizing Antibodies | Baseline up to 1 year | Included only patients who had positive anti-GH antibody. | percentage of participants | NUMBER |
| SECONDARY | Annualized Growth Velocity at Months 6 and 12 (Change From Baseline) | Months 6, 12 | All enrolled participants who received at least one dose of study drug and who had at least one post-baseline assessment | cm/year | MEAN |
| SECONDARY | Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline) | Months 6, 12 | All enrolled participants who received at least one dose of study drug and who had at least one post-baseline assessment | SDS | MEAN |
| SECONDARY | Percentage of Participants With Adverse Events | Baseline up to 1 year | Include all participants who received at least one dose of study drug. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1 | Somatropin | 3.7 | 95% Confidence Interval 0.77 to 10.44 | percentage of participants | |
| Percentage of Participants Who Exhibit Functional Growth Attenuation | Somatropin | 2.6 | 95% Confidence Interval 0.31 to 8.96 | percentage of participants | |
| Percentage of Participants With Neutralizing Antibodies | Somatropin | 0 | percentage of participants | ||
| Annualized Growth Velocity at Months 6 and 12 (Change From Baseline) | Somatropin | 6 months (Anti-GH Antibody Positive) | 5.3 | Standard Deviation 2.89 | cm/year |
| Annualized Growth Velocity at Months 6 and 12 (Change From Baseline) | Somatropin | 6 months (Anti-GH Antibody Negative) | 5.5 | Standard Deviation 2.64 | cm/year |
| Annualized Growth Velocity at Months 6 and 12 (Change From Baseline) | Somatropin | 12 months (Anti-GH Antibody Positive) | 5.2 | Standard Deviation 3.61 | cm/year |
| Annualized Growth Velocity at Months 6 and 12 (Change From Baseline) | Somatropin | 12 months (Anti-GH Antibody Negative) | 4.9 | Standard Deviation 2.40 | cm/year |
| Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline) | Somatropin | 6 months (Anti-GH Antibody Positive) | 0.3 | Standard Deviation 0.11 | SDS |
| Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline) | Somatropin | 6 months (Anti-GH Antibody Negative) | 0.4 | Standard Deviation 0.17 | SDS |
| Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline) | Somatropin | 12 months (Anti-GH Antibody Positive) | 0.8 | Standard Deviation 0.15 | SDS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Somatropin | 82 | |
| Overall Study | Modified ITT Population | Somatropin | 81 | |
| Overall Study | COMPLETED | Somatropin | 78 | |
| Overall Study | NOT COMPLETED | Somatropin | 4 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | Somatropin | 12 | 82 | |
| other | Injection site bruising | General disorders | Somatropin | 7 | 82 | |
| other | Pyrexia | General disorders | Somatropin | 5 | 82 | |
| other | Upper respiratory tract infection | Infections and infestations | Somatropin | 8 | 82 | |
| other | Pharyngitis streptococcal | Infections and infestations | Somatropin | 6 | 82 | |
| other | Nasopharyngitis | Infections and infestations | Somatropin | 5 | 82 | |
| other | Headache | Nervous system disorders | Somatropin | 17 | 82 | |
| other | Rash | Skin and subcutaneous tissue disorders | Somatropin | 6 | 82 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Somatropin | 0 | 82 |
| Total, other adverse events | Somatropin | 40 | 82 |
| Total, serious adverse events | Somatropin | 0 | 82 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02311894
GET https://conductscience.org/api/trials/v1/NCT02311894/registered