CLINICAL TRIALS PROFILE FOR NUTROPIN DEPOT

All Clinical Trials for Nutropin Depot

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00079742 ↗	A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic Fibrosis	Completed	Genentech, Inc.	Phase 2	2003-09-01	This is a Phase II, multicenter, randomized, controlled, open-label trial of the safety and efficacy of Nutropin AQ administered subcutaneously (SC) daily in prepubertal children with CF and growth restriction.
NCT00102258 ↗	Role of Nutrition and Hormones in Boys With Disordered Growth	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	2005-01-19	This study will determine whether adding more calories to the diet helps boys with growth problems grow better while being treated with Nutropin, a growth hormone that is used to help children grow taller. The Food and Drug Administration has approved Nutropin for use in children who are very short. This study will examine whether giving nutritional supplements in addition to Nutropin can help children grow better than with Nutropin alone. Boys between 7 and 10 years of age who are very short and below average in weight, but are otherwise healthy may be eligible for this study. Candidates must qualify for Nutropin treatments to boost their growth. Boys will be recruited for the study from the Nemours Children's Clinic in Jacksonville, FL, and from the National Institutes of Health in Bethesda, MD. Participants are randomly assigned to one of two treatment groups. One group is observed for 6 months and then receives a Nutropin injection every day for 12 months. The second group drinks 8 ounces of a high-calorie beverage called Pediasure every day for 6 months and then receives Nutropin plus Pediasure every day for 12 months. In addition to treatment, participants undergo the following tests and procedures at the schedule indicated: Baseline, 3, 6, 9, 12, 15 and 18 months - Clinical examination - Height measurement - Body composition assessment: Skin-fold thickness calipers are used in four places on the body to estimate body fat - Bioelectric impedance: A small amount of electrical current is used to calculate the percentage of body fat. Baseline, 6, 12, and 18 months - Blood tests - Bone age x-ray: x-ray of the left hand to measure growth potential - DEXA (dual energy x-ray absorptiometry) scan: x-ray scan to measure body fat, muscle, and bone mineral content. The subject lies on a flat table during the scan. Baseline, 6, and 12 months - Record of dietary intake: Parents are asked to write down everything the child eats and drinks for 3 days. Using this record, a dietitian calculates the daily caloric intake. - Total energy expenditure: This test determines how much energy the child uses. For the test, the child drinks water labeled with harmless isotopes (heavy oxygen and heavy hydrogen). For the next 10 days he collects urine in plastic tubes at home. At the end of the 10 days, the parents bring the urine to the clinic for analysis to determine how fast the labeled water leaves the body. This information is used to calculate how much energy the child expends each day. Participants' weight is measured at 2 and 4 weeks, and then monthly for the remainder of the 18-month study.
NCT00134420 ↗	Growth Hormone and Chromosome 18q- and Abnormal Growth	Completed	Genentech, Inc.	Phase 3	2001-02-01	We, the investigators at the University of Texas Health Science Center at San Antonio, want to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH) treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous study showed that growth hormone improved height in all children with 18q- and growth hormone deficiency. In addition, most of the study participants on growth hormone treatment showed an increase in IQ scores.
NCT00134420 ↗	Growth Hormone and Chromosome 18q- and Abnormal Growth	Completed	South Texas Veterans Health Care System	Phase 3	2001-02-01	We, the investigators at the University of Texas Health Science Center at San Antonio, want to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH) treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous study showed that growth hormone improved height in all children with 18q- and growth hormone deficiency. In addition, most of the study participants on growth hormone treatment showed an increase in IQ scores.

Clinical Trial Conditions for Nutropin Depot

Condition Name

Condition Name for Nutropin Depot
Intervention	Trials
Growth Hormone Deficiency	4
Cystic Fibrosis	2
Healthy	1
HIV Infection	1

Condition MeSH

Condition MeSH for Nutropin Depot
Intervention	Trials
Dwarfism, Pituitary	5
Endocrine System Diseases	2
Fibrosis	2
Cystic Fibrosis	2

Clinical Trial Locations for Nutropin Depot

Trials by Country

Trials by Country for Nutropin Depot
Location	Trials
United States	48

Trials by US State

Trials by US State for Nutropin Depot
Location	Trials
New York	5
Texas	4
Florida	4
Minnesota	3
Georgia	2

Clinical Trial Progress for Nutropin Depot

Clinical Trial Phase

Clinical Trial Phase for Nutropin Depot
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Nutropin Depot
Clinical Trial Phase	Trials
Completed	4
Withdrawn	4
Terminated	2

Clinical Trial Sponsors for Nutropin Depot

Sponsor Name

Sponsor Name for Nutropin Depot
Sponsor	Trials
Genentech, Inc.	5
University of Texas Southwestern Medical Center	2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2

Sponsor Type

Sponsor Type for Nutropin Depot
Sponsor	Trials
Other	11
Industry	7
NIH	2