|
Severe Hemophilia B Study Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Severe Hemophilia B Study conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Severe Hemophilia B Study Clinical research trials and Severe Hemophilia B Study health trials occur in a lot of of places throughout 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Severe Hemophilia B Study. Severe Hemophilia B Study Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Severe Hemophilia B Study clinical trial. Human subjects frequently get the finest healthcare available for their Severe Hemophilia B Study condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Severe Hemophilia B Study  Severe Hemophilia B Study
Severe Hemophilia B Study
For Condition: Hemophilia B
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: To characterize the safety and efficacy of rFIX in children less than 6 years of age with severe hemophilia B in the setting of acute bleeding episodes, prophylaxis, and/or surgery.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /5 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Severe hemophilia B (plasma FIX activity level [FIX:C] equal to or <1%) - Less than 5 years of age (in order to complete study treatment before age 6) - In the investigator’s judgment, the patient and/or caregiver will be compliant to study procedures. - The parent or legal guardian has voluntarily signed and dated written informed consent before any screening procedures Exclusion Criteria: - A currently detectable FIX inhibitor (or history of an inhibitor) defined as = or >0.6 BU. A family history of inhibitors will not exclude the patient. - Impaired hepatic function defined as >2.5 X ULN of ALT, AST and/or total bilirubin, except in documented hyperbilirubinemia of the newborn - Impaired renal function (serum creatinine >1.25 ULN) - Albumin < LLN - Platelet count <100,000/mm3 - Abnormal prothrombin time (>1.25 X ULN) - Known hypersensitivity to protein pharmaceuticals or agents related to the test article (eg, hamster proteins) - Documented HIV infection; or has history of infection with Hepatitis B or C - Any other genetic coagulation disorder other than hemophilia B (with the exception of vitamin K-dependent coagulation deficiency of the newborn) - Received any investigational drug within 30 days before entering the study - Any condition (medical or social) that, in the investigator's judgment, makes participation in the study not advisable
Total Enrollment:
Location and Contact Information:
The Emory Clinic - Department of Pediatrics *Recruiting*
Atlanta, Georgia, 30322-1100
United States
Recruiting Thomas Abshire 404-778-5494
University of Texas Houston Medical School *Recruiting*
Houston, Texas, 77030
United States
Recruiting W. Hoots 713-500-8360
St. Christopher's Hospital for Children - Section of Hematology/Oncology *Recruiting*
Philadelphia, Pennsylvania, 19134-1095
United States
Recruiting Frank Shafer 215-427-4399
Additional Information:
Study ID Numbers: 3090A1-301-WW;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037557
Other Hemophilia B Studies:
1. Severe Hemophilia B Study
2. Safety of a New Type of Treatment Called Gene Transfer for the Treatment of Severe Hemophilia B
3. Phase I/II Study of Monoclonal Factor IX Concentrate for Factor IX Deficiency
Related Studies:
Other Hemophilia B Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Severe Hemophilia B Study
|
|
|
|
|
|
|
|
