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Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG) Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG) conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG) Clinical research trials and Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG) medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG). Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG) Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG) clinical trial. Subjects typically recieve the finest healthcare available for their Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG) condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG)  Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG)
Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG)
For Condition: Anemia, Sickle Cell,Hematologic Diseases,Hemoglobinopathies
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To determine whether hydroxyurea prevents the onset of chronic end organ damage in young children with sickle cell anemia.
Details: BACKGROUND: Sickle cell anemia is a complex syndrome with multiple organ system disturbances brought about by the interplay of genetic, humoral, vascular and environmental factors. The clinical course can be one of abrupt and insidious exacerbations and remissions, often migratory and repetitive. These events may result in impairment of function, permanently damaged organs, and ultimately death. Although there is wide variability in the clinical expression of sickle cell disease, this complex set of clinical manifestations is experienced by most patients. In addition, there is no evidence that the primary disease process is different in children when compared with adults with regard to painful episodes. However, children have a higher incidence of respiratory viral infections, and are susceptible to pneumococcal septicemia. With the successful completion of the Multicenter Study of Hydroxyurea (MSH) Trial in adults, attention has now been focused on the use of this agent in children. The Cooperative Study of Sickle Cell Disease (CSSCD) has demonstrated that sickle cell anemia patients with increased painful episode rates die at a younger age. In addition, increased levels of fetal hemoglobin are associated with improved survival, and is probably a reliable childhood forecaster of adult life expectancy. The beneficial effect produced by hydroxyurea is thought to occur because it increases fetal hemoglobin levels. Therefore, if chronic end organ damage can be prevented in early childhood by hydroxyurea administration, and if the crisis rate can be decreased by hydroxyurea use early in life, sickle cell anemia patients may experience increased longevity and an improved quality of life. DESIGN NARRATIVE: The Phase I-Phase II study, HUG-KIDS, examined the safety of hydroxyurea. Children with sickle cell anemia, age 5 to 15 years, were eligible for this multicenter Phase I/II trial. Hydroxyurea was started at 15 mg/kg/d and escalated to 30 mg/kg/d unless the patient experienced laboratory toxicity. Patients were monitored by 2-week visits to assess compliance, toxicity, clinical adverse events, growth parameters, and laboratory efficacy associated with hydroxyurea treatment. Eighty-four children were enrolled between December 1994 and March 1996. Sixty-eight children reached maximum tolerated dose (MTD) and 52 were treated at MTD for 1 year. The study was conducted at four Comprehensive Sickle Cell Centers by the following investigators: Thomas R. Kinney at Duke University Medical Center, Durham, North Carolina; Kwaku Ohene-Frempong at Children's Hospital of Philadelphia; Orah S. Platt at Children's Hospital in Boston; and Elliot Vichinsky at Children's Hospital in Oakland, California. The complete study lasted three years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/18 Years
Genders: Both
Protocol Entry Criteria: Children with sickle cell disease and between the ages of five and eighteen years.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Thomas(Subproject PI), , Duke University
Additional Information:
Study ID Numbers: 315;
Study Start Date: April 1994
Record last reviewed: August 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000602
Other Anemia, Sickle Cell Studies:
1. Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG)
2. Indices of Severity and Prognosis for Sickle Cell Disease
3. Pediatric Hydroxyurea in Sickle Cell Anemia (BABY HUG)
4. Induction of Stable Chimerism for Sickle Cell Anemia
5. Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients
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Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG)
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