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Safety study of Recombinant Factor XIII (rFXIII) in Patients with Congenital Factor XIII Deficiency Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Safety study of Recombinant Factor XIII (rFXIII) in Patients with Congenital Factor XIII Deficiency conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Safety study of Recombinant Factor XIII (rFXIII) in Patients with Congenital Factor XIII Deficiency Clinical research trials and Safety study of Recombinant Factor XIII (rFXIII) in Patients with Congenital Factor XIII Deficiency medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Safety study of Recombinant Factor XIII (rFXIII) in Patients with Congenital Factor XIII Deficiency. Safety study of Recombinant Factor XIII (rFXIII) in Patients with Congenital Factor XIII Deficiency Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Safety study of Recombinant Factor XIII (rFXIII) in Patients with Congenital Factor XIII Deficiency clinical trial. Participants oftentimes recieve the finest healthcare available for their Safety study of Recombinant Factor XIII (rFXIII) in Patients with Congenital Factor XIII Deficiency condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety study of Recombinant Factor XIII (rFXIII) in Patients with Congenital Factor XIII Deficiency  Safety study of Recombinant Factor XIII (rFXIII) in Patients with Congenital Factor XIII Deficiency
Safety study of Recombinant Factor XIII (rFXIII) in Patients with Congenital Factor XIII Deficiency
For Condition: Congenital Factor XIII deficiency
Status: No longer recruiting
Sponsor(s): ZymoGenetics ,
Synopsis: The purpose of this study is to determine the safety of increasing doses of rFXIII in subjects with Congenital Factor XIII Deficiency.
Details: This is a Phase 1, single-site, open-label study to evaluate the safety and pharmacokinetics of escalating doses of rFXIII in subjects with Congenital Factor XIII Deficiency.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Subject is at least 18 years of age at the time of enrollment. - Subject has documented congenital FXIII deficiency. - Subject has normal platelet count and clotting parameters defined as platelet count, PT, PTT, INR, thrombin time and fibrinogen within 2.5% of normal limits. - Subject has adequate renal and hepatic function defined as: creatinine is less or equal to 2.0 mg%, bilirubin is less or equal 1.5 times upper limit of normal; alkaline phosphatase is less or equal to 3 times upper limit of normal and AST is less or equal to 3 times upper limit of normal. - If female and of child-bearing potential, subject has a negative serum pregnancy test within seven (7) days of enrollment. - If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits. - Subject has a negative drug and alcohol screen. - Subject agrees to abstain from alcohol intake for 24 hours prior to admittance to the test facility and during the confinement period. - Patient has signed an IRB-approved informed consent form. Exclusion Criteria - Subject has received blood products or FXIII concentrates within four weeks of study enrollment. - Subject has known antibodies to FXIII. - Subject has a hereditary or acquired coagulation disorder other than FXIII deficiency. - Subject has a previous history of autoimmune disorder involving autoantibodies, e.g., systemic lupus erythematosus. - Subject has a previous history of thromboembolic events, e.g., cerebrovascular accident or deep vein thrombosis or who has received any antithrombotic or anti-platelet drugs within 7 days of study enrollment. - Subject has received treatment with any experimental agent within 30 days of study enrollment. - Subject is pregnant or lactating. - Subject has any concurrent serious chronic or acute illness or infection. - Subject has had any surgical procedure in the 30 days prior to enrollment. - Subject has donated blood within 30 days prior to enrollment. - Subject has medical, social or psychosocial factors expected to impact compliance or safety.
Total Enrollment: 12
Location and Contact Information:
Children's Hospital of Orange County
Orange, California, 92868
United States
Additional Information:
Study ID Numbers: CD1;
Study Start Date: February 2003
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056589
Other Congenital Factor Xiii Deficiency Studies:
1. Safety study of Recombinant Factor XIII (rFXIII) in Patients with Congenital Factor XIII Deficiency
Related Studies:
Other Congenital Factor XIII deficiency Clinical Trials
Other California Clinical Trials
Other Orange Clinical Trials
Safety study of Recombinant Factor XIII (rFXIII) in Patients with Congenital Factor XIII Deficiency
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