CLINICAL TRIALS PROFILE FOR MECASERMIN RECOMBINANT
✉ Email this page to a colleague
All Clinical Trials for Mecasermin Recombinant
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00330668 ↗ | Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency | Terminated | Ipsen | Phase 3 | 2005-11-01 | This is an extension study to Tercica study MS301 (NCT00125164) and is intended to collect long term safety and efficacy data on the continued use of recombinant human insulin-like growth factor-1 (rh IGF-1) in children and adolescents treated for primary IGF-1 deficiency (IGFD). The secondary objective is to use the data collected to learn more about the relationship of IGF-1 exposure to the promotion of normal growth and pubertal development. |
| 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 | 2007-06-01 | 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. ... |
| NCT00566241 ↗ | IGF-1 Therapy in Patients With Cystic Fibrosis | Terminated | Stony Brook University | Phase 1 | 2008-06-01 | 28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and composition in adults with cystic fibrosis. |
| NCT00571727 ↗ | Long-Term Treatment With rhIGF-1 in GHIS | Completed | University of Oklahoma | Phase 2/Phase 3 | 1990-01-01 | 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 | 1990-01-01 | Long term study of the effects of dosing with rhIGF-1 on growth |
| NCT00903110 ↗ | European Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry | Recruiting | Ipsen | 2008-12-09 | The Eu-IGFD is a descriptive, multicenter, observational, prospective, open-ended, non interventional, post-authorisation surveillance registry. The purpose of this study is to collect long-term safety information on the use of recombinant DNA-derived human Insulin-like Growth Factor-1 (rhIGF-I) Increlex® replacement therapy for the treatment of children with growth failure. | |
| NCT01253317 ↗ | Treatment of Rett Syndrome With rhIGF-1 (Mecasermin [rDNA]Injection) | Completed | Autism Speaks | Phase 1 | 2010-12-01 | The investigators are recruiting children for a research study using a medication known as IGF-1 (mecasermin or INCRELEX) to see if it improves the health of children with Rett syndrome (RTT). To participate in the study your child must be female, between the ages of 2 to 12 and have a genetic diagnosis (MECP2 deletion or mutation) of Rett Syndrome. As you may know, there is no treatment for this illness. Currently, the standard management of Rett syndrome is supportive, which means attempting to prevent complications and treatment of symptoms. This study involves testing an investigational drug, which means that even though IGF-1 is approved by the Food and Drug Administration (FDA) for use in children, it has not been used before to treat Rett syndrome specifically. Information from this research will help determine whether the drug should be approved by the FDA in the future for the treatment of Rett Syndrome. There are five major goals to this study: 1. As one of the features of Rett Syndrome is unstable vital signs, the investigators are trying to determine if IGF-1 has any effect on normalizing your child's pulse, blood pressure and breathing pattern. 2. The safety of IGF-1 in children with Rett syndrome. The study personnel will ask you to complete a medication diary and side effect reporting form on a regular basis. They will assist you in completing this by telephone interviews. Your child will undergo 2 lumbar punctures performed at the bedside in the clinical research facility. In addition, laboratory tests will be performed throughout the study to evaluate the safety of IGF-1. These will be blood tests similar to those provided in routine clinical care. Your child will undergo regular non-invasive comprehensive physical examinations including neurological and eye examination, tonsil evaluation, electrocardiograms (ECG), measurement of height, weight and head circumference. 3. IGF-1 may improve your child's behavior, communication and speech. In order to measure this, the investigators will evaluate your child once during each month of treatment with neurodevelopmental assessments and a neurological exam. Investigators will also ask you about her behavior and day-to-day functioning through a structured parental interview and questionnaires. 4. We will examine your child's cortical function through use of electroencephalography (EEG) in conjunction with presentation of visual and auditory stimuli. EEG is a non-invasive way of recording the electrical activity of your child's brain. 5. Children with Rett Syndrome sometimes experience "flushing" in their cheeks or have exceptionally cold hands or feet and/or abnormal perspiration. The Qsensor® is a non-invasive device worn on a fabric bracelet that continually measures your child's perspiration level and body temperature. We would like to use the Qsensor® to determine whether or not IGF-1 improves these symptoms. . |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for Mecasermin Recombinant
Condition Name
Clinical Trial Locations for Mecasermin Recombinant
Trials by Country
Clinical Trial Progress for Mecasermin Recombinant
Clinical Trial Phase
Clinical Trial Sponsors for Mecasermin Recombinant
Sponsor Name
