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 ID: NCT02311894
Last Updated: 2019-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
82 participants
INTERVENTIONAL
2015-03-31
2017-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Somatropin
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
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.
Interventions
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Somatropin
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
3 Years
14 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
Children'S Hospital of Orange County
Orange, California, United States
Center of Excellence in Diabetes & Endocrinology
Sacramento, California, United States
San Diego Medical Group; Pediatric Endocrinology
San Diego, California, United States
Rocky Mountain Pediatric Endocrinology, PC
Centennial, Colorado, United States
Pediatric Endocrine Associates
Greenwood Village, Colorado, United States
Nemours Children's Clinic - of the Nemours Foundation
Jacksonville, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Nemours Childrens Clinic
Orlando, Florida, United States
The Pediatric Endocrine Office of Larry C. Deeb
Tallahassee, Florida, United States
Pediatric Endrocine Assoc
Tampa, Florida, United States
USF Diabetes Center
Tampa, Florida, United States
Emory Children's Center
Atlanta, Georgia, United States
University of Louisville
Louisville, Kentucky, United States
Barry J Reiner, MD, LLC
Baltimore, Maryland, United States
Boston Childrens Hospital
Boston, Massachusetts, United States
Baystate Endocrinology and Diabetes; Baystate Children's Specialty Center, Pediatric Endocrinology
Springfield, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota Childrens' Hospital
Minneapolis, Minnesota, United States
Children's Healthcare d.b.a Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, United States
Children's Mercy Hospitals & Clinics; Pulmonology
Kansas City, Missouri, United States
Hackensack University Medical Center PARTNER
Hackensack, New Jersey, United States
New York Presbyterian Hospital
New York, New York, United States
UNC General Pediatrics Clinic
Chapel Hill, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Milton S Hershey Ped Sub Spclt
Hershey, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina; MUSC Pediatric Endocrinology
Charleston, South Carolina, United States
Endocrine Associates of Dallas
Dallas, Texas, United States
Cook Children's Hospital
Fort Worth, Texas, United States
MultiCare Health System Institute for Research and Innovation
Tacoma, Washington, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ML29543
Identifier Type: -
Identifier Source: org_study_id
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