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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR NUTROPIN DEPOT

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Clinical Trials for Nutropin Depot

Trial ID Title Status Sponsor Phase Summary
NCT00079742 A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic Fibrosis Completed Genentech, Inc. Phase 2 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 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 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 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 The University of Texas Health Science Center at San Antonio Phase 3 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.
NCT00209235 Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments Recruiting Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2/Phase 3 We, the researchers, have found that growth hormone deficiency is very common in patients with pseudohypoparathyroidism type 1a, which falls under the broader condition termed Albright hereditary osteodystrophy. Patients with pseudohypoparathyroidism type 1a typically are short and obese. Some of these patients are not short during childhood, but due to a combination of factors, they end up short as adults. We are evaluating the effect of growth hormone treatment in those patients with pseudohypoparathyroidism type 1a who are found to be growth hormone deficient. We hypothesize that growth hormone deficiency may contribute to the short stature and obesity found in this condition. We are also evaluating the effect of growth hormone on patients with pseudohypoparathyroidism type 1a who are not growth hormone deficient (i.e., growth hormone sufficient) in those who had been on study drug through R01 FD003409 or who meet the criteria of idiopathic short stature or SGA. We are also evaluating neurocognitive and psychosocial functioning in participants with AHO in order to determine the specific impairments that are most common in the condition and to determine the best approach toward management. Funding source -- Growth hormone study: FDA OOPD [R01 FD003409 (which has ended) and R01 FD002568 (which has ended)] Cognitive/behavior: NICHD R21 HD078864
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Nutropin Depot

Condition Name

Condition Name for Nutropin Depot
Intervention Trials
Growth Hormone Deficiency 4
Cystic Fibrosis 2
Constitutional Delay of Growth and Development 1
Healthy 1
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Condition MeSH

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

Trials by Country

Trials by Country for Nutropin Depot
Location Trials
United States 46
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Trials by US State

Trials by US State for Nutropin Depot
Location Trials
New York 4
Florida 4
Texas 4
Minnesota 3
Missouri 2
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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
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Clinical Trial Status

Clinical Trial Status for Nutropin Depot
Clinical Trial Phase Trials
Completed 3
Unknown status 3
Withdrawn 2
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Clinical Trial Sponsors for Nutropin Depot

Sponsor Name

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

Sponsor Type for Nutropin Depot
Sponsor Trials
Other 8
Industry 7
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Healthtrust
Deloitte
Julphar
Baxter
Cerilliant
Federal Trade Commission
Chinese Patent Office
Daiichi Sankyo

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