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Cooperative Study of Factor VIII Inhibitors Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Cooperative Study of Factor VIII Inhibitors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Cooperative Study of Factor VIII Inhibitors Clinical research trials and Cooperative Study of Factor VIII Inhibitors healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Cooperative Study of Factor VIII Inhibitors. Cooperative Study of Factor VIII Inhibitors Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Cooperative Study of Factor VIII Inhibitors clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Cooperative Study of Factor VIII Inhibitors condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Cooperative Study of Factor VIII Inhibitors  Cooperative Study of Factor VIII Inhibitors
Cooperative Study of Factor VIII Inhibitors
For Condition: Blood Coagulation Disorders,Hematologic Diseases,Hemophilia A,Hemorrhagic Disorders
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To test the efficacy of prothrombin complex concentrates (Factor IX) in the treatment of hemophiliac patients who had inhibitors to Factor VIII.
Details: BACKGROUND: Despite major advances in the treatment of patients with hemophilia, a serious remaining challenge was presented by the occurrence of circulating inhibitors to Factor VIII. Because of lack of information on the natural course of patients with Factor VIII inhibitors, the relative efficacy of various modes of therapy was not established. The Division of Blood Diseases and Resources decided to sponsor a clinical investigation which would evaluate populations of hemophilia patients for Factor VIII inhibitors, follow up these patients to provide information on the natural history of the inhibitor in the hemophilia patients, and make available a reference center to monitor results and attain uniformity. Treatment of a patient with a severe inhibitor and consequent bleeding remained a problem. Management included protracted treatment with Factor VIII, use of immunosuppressive agents and prothrombin complex (or Factor IX) concentrates. The rationale for Factor IX was that it bypassed the defect in Factor VIII caused by the inhibitor. This method of therapy attracted wide popularity, but the success was greatly debated. It was intended at the very outset of the Factor VIII study that therapeutic trials involving patients with inhibitors would not be a prime function, but that such studies would be monitored if necessary. A controlled trial of Factor IX concentrates therapy was strongly advised by the DBDR Advisory Committee. Accordingly, during fiscal year 1978, a protocol for a double-blind control study was developed by the Factor VIII inhibitor group. The trial began in the spring of 1978, and the intervention terminated about one year later. DESIGN NARRATIVE: Double-blind study; patients served as their own controls. A total of 51 patients each received a single large dose of Konyne, Proplex, or diluted albumin (as a control). Joint bleeding of the elbow, knee, and ankle was evaluated six hours after each dose.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Male
Protocol Entry Criteria: Males with hemophilia, not stratified as to ethnic group.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LouisAledort, , Mount Sinai Medical Center
Additional Information:
Study ID Numbers: 302;
Study Start Date: July 1978
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000582
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Cooperative Study of Factor VIII Inhibitors
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