A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency

Completed · Phase 4

Conditions studied: Growth Hormone Deficiency

In brief

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.

Key facts

Study ID

NCT02311894

Run by

Genentech, Inc.

People needed

82

Starts

2015-03-31

Expected to finish

2017-11-08

Last updated by the study team

2019-01-08

Who can join

Age: 3 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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