Phase 4
N=82
A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
Growth Hormone Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT02311894 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1 — 3.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Somatropin (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1 |
3.7 | — |
| SECONDARY Percentage of Participants Who Exhibit Functional Growth Attenuation |
2.6 | — |
| SECONDARY Percentage of Participants With Neutralizing Antibodies |
— | — |
| SECONDARY Annualized Growth Velocity at Months 6 and 12 (Change From Baseline) |
5.3; 5.5; 5.2; 4.9 | — |
| SECONDARY Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline) |
0.3; 0.4; 0.8; 0.7 | — |
| SECONDARY Percentage of Participants With Adverse Events |
69.5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Bone age less than equal to ( ] 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
Data sourced from ClinicalTrials.gov (NCT02311894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.