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

Last updated: December 19, 2018
Sponsor: Genentech, Inc.
Overall Status: Completed

Phase

4

Condition

Hormone Deficiencies

Growth Hormone Deficiencies/abnormalities

Severe Short Stature

Treatment

N/A

Clinical Study ID

NCT02311894
ML29543
  • Ages 3-14
  • All Genders

Study 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

Inclusion Criteria:

  • Bone age less than equal to (</=) 9 years (females) or </= 11 years (males) asdetermined by X-ray of the left hand and wrist using Greulich and Pyle method andobtained 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]) bytwo standard pharmacologic tests obtained up to 12 months prior to informedconsent/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 deviationscore (SDS) </= 5th percentile for idiopathic isolated GHD participants

Exclusion

Exclusion Criteria:

  • Any previous rhGH treatment

  • Short stature etiologies other than GHD

  • Acute critical illness or uncontrolled chronic illness, which in the opinion of theinvestigator 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 ofcorticosteroids 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 investigatorbelieves 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 forgrowth failure, or treatment with a biologic agent

  • Participants with closed epiphyses

  • Participants with a known hypersensitivity to somatropin, excipients, or diluent

Study Design

Total Participants: 82
Study Start date:
March 31, 2015
Estimated Completion Date:
November 08, 2017

Connect with a study center

  • Arkansas Children's Hospital Research Institute

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Valley Children's Hospital

    Madera, California 93636
    United States

    Site Not Available

  • Children'S Hospital of Orange County

    Orange, California 92868-3874
    United States

    Site Not Available

  • Center of Excellence in Diabetes & Endocrinology

    Sacramento, California 95821
    United States

    Site Not Available

  • San Diego Medical Group; Pediatric Endocrinology

    San Diego, California 92123
    United States

    Site Not Available

  • Rocky Mountain Pediatric Endocrinology, PC

    Centennial, Colorado 80112
    United States

    Site Not Available

  • Pediatric Endocrine Associates

    Greenwood Village, Colorado 80111
    United States

    Site Not Available

  • Nemours Children's Clinic - of the Nemours Foundation

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Miami Children's Hospital

    Miami, Florida 33155-3009
    United States

    Site Not Available

  • Nemours Childrens Clinic

    Orlando, Florida 32801
    United States

    Site Not Available

  • The Pediatric Endocrine Office of Larry C. Deeb

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Pediatric Endrocine Assoc

    Tampa, Florida 33607
    United States

    Site Not Available

  • USF Diabetes Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Emory Children's Center

    Atlanta, Georgia 20010
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Barry J Reiner, MD, LLC

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • Boston Childrens Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Baystate Endocrinology and Diabetes; Baystate Children's Specialty Center, Pediatric Endocrinology

    Springfield, Massachusetts 01199
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109-0934
    United States

    Site Not Available

  • University of Minnesota Childrens' Hospital

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • University of Minnesota Childrens' Hospital

    Minneapolos, Minnesota 55014
    United States

    Site Not Available

  • Children's Healthcare d.b.a Children's Hospitals and Clinics of Minnesota

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • Children's Healthcare d.b.a Children's Hospitals and Clinics of Minnesota

    St. Paul, Minnesota 55102
    United States

    Site Not Available

  • Children's Mercy Hospitals & Clinics; Pulmonology

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Hackensack University Medical Center PARTNER

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • New York Presbyterian Hospital

    New York, New York 10021
    United States

    Site Not Available

  • UNC General Pediatrics Clinic

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Milton S Hershey Ped Sub Spclt

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Medical University of South Carolina; MUSC Pediatric Endocrinology

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Endocrine Associates of Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Cook Children's Hospital

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • MultiCare Institute for Research and Innovation

    Covington, Washington 98042
    United States

    Site Not Available

  • MultiCare Health System Institute for Research and Innovation

    Tacoma, Washington 98405
    United States

    Site Not Available

  • MultiCare Institute for Research and Innovation

    Tacoma, Washington 98405
    United States

    Site Not Available

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