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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR INCRELEX

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Clinical Trials for Increlex

Trial ID Title Status Sponsor Phase Summary
NCT00490100 Treatment for Growth Failure in Patients With X-Linked Severe Combined Immunodeficiency: Phase 2 Study of Insulin-Like Growth Factor-1 Terminated National Institute of Allergy and Infectious Diseases (NIAID) Phase 1/Phase 2 This study will evaluate the safety and effectiveness of insulin-like growth factor-1 (IGF-1) to treat patients with X-linked severe combined immunodeficiency (XSCID). Those who have XSCID lack white blood cells that protect their bodies from invasion by all types of germs. IGF-1 is the main hormone responsible for the body's growth and metabolism. As a medication, IGF-1 is Increlex[(Trademark)] (mecasermin), Patients ages 2 to 20 who have not yet begun puberty, have a diagnosis of XSCID, and are shorter than the 3rd percentile for their age may be eligible for this study. This study will last about 3 years, and patients' visits will be scheduled at 3-month intervals. Patients will have a physical history and exam, X-rays, electrocardiogram, blood tests, and body measurements. Patients will take estradiol orally for 2 days, to help avoid false results of growth hormone (GH) levels in blood samples. Then provocation testing is done, with two tests back to back. It determines blood levels of GH and the body's response to testing with drugs called arginine and clonidine. Patients are admitted to the pediatric inpatient unit and will have an intravenous (IV) line placed in the arm. Arginine is given by IV over 30 minutes, and blood samples are taken. Right after arginine testing, the clonidine tablet is given. The IGF-1 generation test is then done to see if the body makes IGF-1 as a product in response to injections of GH for 5 consecutive days. This test does not require that patients are inpatients, but after Day 8, patients must be admitted to the pediatric unit to have blood sampling, start Increlex injections, and start close monitoring of blood sugar levels. They will learn how to do a self-injection and follow other advice. They will complete records about the injection site, symptoms, and side effects-keeping records for at least the first 2 days after going home, with each dose change, and as needed. Patients stick their fingertip and place a small drop of blood on a blood sugar monitoring strip. The strip is put into a glucometer-a small hand-held device to measure the blood sugar level. Patients will be instructed to always have a source of sugar available in case blood sugar is too low.
NCT00516386 Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents Completed Tercica Phase 1/Phase 2 The purpose of this study was to determine whether giving insulin like growth factor-I (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone formation markers.
NCT00516386 Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents Completed Massachusetts General Hospital Phase 1/Phase 2 The purpose of this study was to determine whether giving insulin like growth factor-I (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone formation markers.
NCT00571727 Long-Term Treatment With rhIGF-1 in GHIS Completed University of Oklahoma Phase 2/Phase 3 Long term study of the effects of dosing with rhIGF-1 on growth
NCT00571727 Long-Term Treatment With rhIGF-1 in GHIS Completed Ipsen Phase 2/Phase 3 Long term study of the effects of dosing with rhIGF-1 on growth
NCT00572156 rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency Terminated Ipsen Phase 2 IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in response to another hormone called growth hormone. Growth Hormone is produced by a small gland at the base of the brain (the pituitary). Together IGF-1 and GH are large contributors to growth during infancy, childhood, and adolescence. Children with IGF Deficiency are short and have an imbalance in the levels of growth hormone and IGF-1 that their body produces. Their growth hormone levels are normal or even high, but IGF-1 levels do not increase normally in response to growth hormone. As a result, they have a type of growth hormone insensitivity and an inability to grow normally. This study is a test to see whether daily dosing with a combination of rhIGF-1 and rhGH will help children with IGFD grow taller more quickly than children treated with rhGH alone. The study medications, rhIGF-1 and rhGH, are approved by the US Food and Drug Administration (FDA) for use in some growth disorders in children, but the combination of rhIGF-1 and rhGH in children with IGF-1 deficiency (IGFD) is investigational.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Increlex

Condition Name

Condition Name for Increlex
Intervention Trials
Rett Syndrome 2
Anorexia Nervosa 2
Growth Failure 2
Osteopenia 1
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Condition MeSH

Condition MeSH for Increlex
Intervention Trials
Syndrome 4
Anorexia Nervosa 2
Anorexia 2
Rett Syndrome 2
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Clinical Trial Locations for Increlex

Trials by Country

Trials by Country for Increlex
Location Trials
United States 11
Sweden 1
United Kingdom 1
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Trials by US State

Trials by US State for Increlex
Location Trials
Massachusetts 4
New York 2
California 2
Texas 1
Ohio 1
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Clinical Trial Progress for Increlex

Clinical Trial Phase

Clinical Trial Phase for Increlex
Clinical Trial Phase Trials
Phase 2/Phase 3 2
Phase 2 4
Phase 1/Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Increlex
Clinical Trial Phase Trials
Completed 5
Terminated 4
Recruiting 3
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Clinical Trial Sponsors for Increlex

Sponsor Name

Sponsor Name for Increlex
Sponsor Trials
Ipsen 3
Icahn School of Medicine at Mount Sinai 2
Massachusetts General Hospital 2
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Sponsor Type

Sponsor Type for Increlex
Sponsor Trials
Other 15
Industry 5
NIH 2
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