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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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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02311894
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 82 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Years to 14 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2015 (Actual)
- Primary completion
- Nov 8, 2017 (Actual)
- Completion
- Nov 8, 2017 (Actual)
- Last update posted
- Jan 8, 2019
2015 – 2017
United States locations
- U.S. sites
- 33
- U.S. states
- 20
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Children's Hospital Research Institute | Little Rock | Arkansas | 72202 | — |
| Children'S Hospital of Orange County | Orange | California | 92868-3874 | — |
| Center of Excellence in Diabetes & Endocrinology | Sacramento | California | 95821 | — |
| San Diego Medical Group; Pediatric Endocrinology | San Diego | California | 92123 | — |
| Rocky Mountain Pediatric Endocrinology, PC | Centennial | Colorado | 80112 | — |
| Pediatric Endocrine Associates | Greenwood Village | Colorado | 80111 | — |
| Nemours Children's Clinic - of the Nemours Foundation | Jacksonville | Florida | 32207 | — |
| Miami Children's Hospital | Miami | Florida | 33155-3009 | — |
| Nemours Childrens Clinic | Orlando | Florida | 32801 | — |
| The Pediatric Endocrine Office of Larry C. Deeb | Tallahassee | Florida | 32308 | — |
| Pediatric Endrocine Assoc | Tampa | Florida | 33607 | — |
| USF Diabetes Center | Tampa | Florida | 33612 | — |
| Emory Children's Center | Atlanta | Georgia | 20010 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Barry J Reiner, MD, LLC | Baltimore | Maryland | 21229 | — |
| Boston Childrens Hospital | Boston | Massachusetts | 02115 | — |
| Baystate Endocrinology and Diabetes; Baystate Children's Specialty Center, Pediatric Endocrinology | Springfield | Massachusetts | 01199 | — |
| University of Michigan | Ann Arbor | Michigan | 48109-0934 | — |
| University of Minnesota Childrens' Hospital | Minneapolis | Minnesota | 55455 | — |
| Children's Healthcare d.b.a Children's Hospitals and Clinics of Minnesota | Saint Paul | Minnesota | 55102 | — |
| Children's Mercy Hospitals & Clinics; Pulmonology | Kansas City | Missouri | 64108 | — |
| Hackensack University Medical Center PARTNER | Hackensack | New Jersey | 07601 | — |
| New York Presbyterian Hospital | New York | New York | 10021 | — |
| UNC General Pediatrics Clinic | Chapel Hill | North Carolina | 27514 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Milton S Hershey Ped Sub Spclt | Hershey | Pennsylvania | 17033 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Medical University of South Carolina; MUSC Pediatric Endocrinology | Charleston | South Carolina | 29425 | — |
| Endocrine Associates of Dallas | Dallas | Texas | 75231 | — |
| Cook Children's Hospital | Fort Worth | Texas | 76104 | — |
| MultiCare Health System Institute for Research and Innovation | Tacoma | Washington | 98405 | — |
| MultiCare Institute for Research and Innovation | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02311894, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 8, 2019 · Synced Nov 12, 2026
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