Phase
Condition
Hormone Deficiencies
Growth Hormone Deficiencies/abnormalities
Severe Short Stature
Treatment
N/AClinical Study ID
Ages 3-14 All Genders
Study Summary
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
Connect with a study center
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas 72202
United StatesSite Not Available
Valley Children's Hospital
Madera, California 93636
United StatesSite Not Available
Children'S Hospital of Orange County
Orange, California 92868-3874
United StatesSite Not Available
Center of Excellence in Diabetes & Endocrinology
Sacramento, California 95821
United StatesSite Not Available
San Diego Medical Group; Pediatric Endocrinology
San Diego, California 92123
United StatesSite Not Available
Rocky Mountain Pediatric Endocrinology, PC
Centennial, Colorado 80112
United StatesSite Not Available
Pediatric Endocrine Associates
Greenwood Village, Colorado 80111
United StatesSite Not Available
Nemours Children's Clinic - of the Nemours Foundation
Jacksonville, Florida 32207
United StatesSite Not Available
Miami Children's Hospital
Miami, Florida 33155-3009
United StatesSite Not Available
Nemours Childrens Clinic
Orlando, Florida 32801
United StatesSite Not Available
The Pediatric Endocrine Office of Larry C. Deeb
Tallahassee, Florida 32308
United StatesSite Not Available
Pediatric Endrocine Assoc
Tampa, Florida 33607
United StatesSite Not Available
USF Diabetes Center
Tampa, Florida 33612
United StatesSite Not Available
Emory Children's Center
Atlanta, Georgia 20010
United StatesSite Not Available
University of Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
Barry J Reiner, MD, LLC
Baltimore, Maryland 21229
United StatesSite Not Available
Boston Childrens Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Baystate Endocrinology and Diabetes; Baystate Children's Specialty Center, Pediatric Endocrinology
Springfield, Massachusetts 01199
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109-0934
United StatesSite Not Available
University of Minnesota Childrens' Hospital
Minneapolis, Minnesota 55455
United StatesSite Not Available
University of Minnesota Childrens' Hospital
Minneapolos, Minnesota 55014
United StatesSite Not Available
Children's Healthcare d.b.a Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota 55102
United StatesSite Not Available
Children's Healthcare d.b.a Children's Hospitals and Clinics of Minnesota
St. Paul, Minnesota 55102
United StatesSite Not Available
Children's Mercy Hospitals & Clinics; Pulmonology
Kansas City, Missouri 64108
United StatesSite Not Available
Hackensack University Medical Center PARTNER
Hackensack, New Jersey 07601
United StatesSite Not Available
New York Presbyterian Hospital
New York, New York 10021
United StatesSite Not Available
UNC General Pediatrics Clinic
Chapel Hill, North Carolina 27514
United StatesSite Not Available
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Oregon Health and Science University
Portland, Oregon 97239
United StatesSite Not Available
Milton S Hershey Ped Sub Spclt
Hershey, Pennsylvania 17033
United StatesSite Not Available
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Medical University of South Carolina; MUSC Pediatric Endocrinology
Charleston, South Carolina 29425
United StatesSite Not Available
Endocrine Associates of Dallas
Dallas, Texas 75231
United StatesSite Not Available
Cook Children's Hospital
Fort Worth, Texas 76104
United StatesSite Not Available
MultiCare Institute for Research and Innovation
Covington, Washington 98042
United StatesSite Not Available
MultiCare Health System Institute for Research and Innovation
Tacoma, Washington 98405
United StatesSite Not Available
MultiCare Institute for Research and Innovation
Tacoma, Washington 98405
United StatesSite Not Available

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