A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
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|ClinicalTrials.gov Identifier: NCT02311894|
Recruitment Status : Completed
First Posted : December 9, 2014
Results First Posted : November 15, 2018
Last Update Posted : November 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Growth Hormone Deficiency||Drug: Somatropin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IV, Multicenter, Open-Label Study of the Immunogenicity of Nutropin AQ® V1.1 [Somatropin (rDNA Origin) Injection] Administered Daily to Naïve Growth Hormone-Deficient Children (iSTUDY)|
|Actual Study Start Date :||March 31, 2015|
|Actual Primary Completion Date :||November 8, 2017|
|Actual Study Completion Date :||November 8, 2017|
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.
Somatropin will be administered as SC injections at a dose of up to 0.043 mg/kg/day. The dose may be adjusted for a change in body weight of at least (plus [+]/minus [-]) 2 kilograms (kg) from baseline at the Month 6 study visit or for a change in insulin-growth factor-1 (IGF-1), as per investigator assessment.
Other Name: Nutropin AQ v1.1
- Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1 [ Time Frame: Baseline up to 1 year ]Participants who were tested positive to anti-GH antibody after initiation of study treatment.
- Percentage of Participants Who Exhibit Functional Growth Attenuation [ Time Frame: 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.
- Percentage of Participants With Neutralizing Antibodies [ Time Frame: 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.
- Annualized Growth Velocity at Months 6 and 12 (Change From Baseline) [ Time Frame: 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).
- Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline) [ Time Frame: 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.
- Percentage of Participants With Adverse Events [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311894
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|Study Director:||Clinical Trials||Hoffmann-La Roche|