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

PHASE4CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

November 8, 2017

Study Completion Date

November 8, 2017

Conditions
Growth Hormone Deficiency
Interventions
DRUG

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.

Trial Locations (33)

10021

New York Presbyterian Hospital, New York

17033

Milton S Hershey Ped Sub Spclt, Hershey

19107

Thomas Jefferson University Hospital, Philadelphia

20010

Emory Children's Center, Atlanta

21229

Barry J Reiner, MD, LLC, Baltimore

27514

UNC General Pediatrics Clinic, Chapel Hill

29425

Medical University of South Carolina; MUSC Pediatric Endocrinology, Charleston

32207

Nemours Children's Clinic - of the Nemours Foundation, Jacksonville

32308

The Pediatric Endocrine Office of Larry C. Deeb, Tallahassee

32801

Nemours Childrens Clinic, Orlando

33607

Pediatric Endrocine Assoc, Tampa

33612

USF Diabetes Center, Tampa

40202

University of Louisville, Louisville

55102

Children's Healthcare d.b.a Children's Hospitals and Clinics of Minnesota, Saint Paul

55455

University of Minnesota Childrens' Hospital, Minneapolis

64108

Children's Mercy Hospitals & Clinics; Pulmonology, Kansas City

72202

Arkansas Children's Hospital Research Institute, Little Rock

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75231

Endocrine Associates of Dallas, Dallas

76104

Cook Children's Hospital, Fort Worth

80111

Pediatric Endocrine Associates, Greenwood Village

80112

Rocky Mountain Pediatric Endocrinology, PC, Centennial

92123

San Diego Medical Group; Pediatric Endocrinology, San Diego

95821

Center of Excellence in Diabetes & Endocrinology, Sacramento

97239

Oregon Health and Science University, Portland

98405

MultiCare Health System Institute for Research and Innovation, Tacoma

MultiCare Institute for Research and Innovation, Tacoma

92868-3874

Children'S Hospital of Orange County, Orange

33155-3009

Miami Children's Hospital, Miami

02115

Boston Childrens Hospital, Boston

01199

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

48109-0934

University of Michigan, Ann Arbor

07601

Hackensack University Medical Center PARTNER, Hackensack

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY