A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
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)
1 other identifier
interventional
82
1 country
33
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2015
Typical duration for phase_4
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2014
CompletedFirst Posted
Study publicly available on registry
December 9, 2014
CompletedStudy Start
First participant enrolled
March 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2017
CompletedResults Posted
Study results publicly available
November 15, 2018
CompletedJanuary 8, 2019
December 1, 2018
2.6 years
December 4, 2014
October 19, 2018
December 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1
Participants who were tested positive to anti-GH antibody after initiation of study treatment.
Baseline up to 1 year
Secondary Outcomes (5)
Percentage of Participants Who Exhibit Functional Growth Attenuation
Baseline up to 1 year
Percentage of Participants With Neutralizing Antibodies
Baseline up to 1 year
Annualized Growth Velocity at Months 6 and 12 (Change From Baseline)
Months 6, 12
Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline)
Months 6, 12
Percentage of Participants With Adverse Events
Baseline up to 1 year
Study Arms (1)
Somatropin
EXPERIMENTALChildren 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (33)
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202, United States
Children'S Hospital of Orange County
Orange, California, 92868-3874, United States
Center of Excellence in Diabetes & Endocrinology
Sacramento, California, 95821, United States
San Diego Medical Group; Pediatric Endocrinology
San Diego, California, 92123, United States
Rocky Mountain Pediatric Endocrinology, PC
Centennial, Colorado, 80112, United States
Pediatric Endocrine Associates
Greenwood Village, Colorado, 80111, United States
Nemours Children's Clinic - of the Nemours Foundation
Jacksonville, Florida, 32207, United States
Miami Children's Hospital
Miami, Florida, 33155-3009, United States
Nemours Childrens Clinic
Orlando, Florida, 32801, United States
The Pediatric Endocrine Office of Larry C. Deeb
Tallahassee, Florida, 32308, United States
Pediatric Endrocine Assoc
Tampa, Florida, 33607, United States
USF Diabetes Center
Tampa, Florida, 33612, United States
Emory Children's Center
Atlanta, Georgia, 20010, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Barry J Reiner, MD, LLC
Baltimore, Maryland, 21229, United States
Boston Childrens Hospital
Boston, Massachusetts, 02115, United States
Baystate Endocrinology and Diabetes; Baystate Children's Specialty Center, Pediatric Endocrinology
Springfield, Massachusetts, 01199, United States
University of Michigan
Ann Arbor, Michigan, 48109-0934, United States
University of Minnesota Childrens' Hospital
Minneapolis, Minnesota, 55455, United States
Children's Healthcare d.b.a Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, 55102, United States
Children's Mercy Hospitals & Clinics; Pulmonology
Kansas City, Missouri, 64108, United States
Hackensack University Medical Center PARTNER
Hackensack, New Jersey, 07601, United States
New York Presbyterian Hospital
New York, New York, 10021, United States
UNC General Pediatrics Clinic
Chapel Hill, North Carolina, 27514, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Milton S Hershey Ped Sub Spclt
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina; MUSC Pediatric Endocrinology
Charleston, South Carolina, 29425, United States
Endocrine Associates of Dallas
Dallas, Texas, 75231, United States
Cook Children's Hospital
Fort Worth, Texas, 76104, United States
MultiCare Health System Institute for Research and Innovation
Tacoma, Washington, 98405, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2014
First Posted
December 9, 2014
Study Start
March 31, 2015
Primary Completion
November 8, 2017
Study Completion
November 8, 2017
Last Updated
January 8, 2019
Results First Posted
November 15, 2018
Record last verified: 2018-12