FEIBA NF: A prospective, open-label, randomized, parallel study to evaluate efficacy and safety of prophylactic versus on-demand treatment in subjects with hemophilia A or B and a high titer inhibitor - FEIBA NF Prophylaxis Study

Baxter Innovations GmbH0 个研究点目标入组 36 人开始时间: 2009年6月26日最近更新: 2019年6月30日

适应症

试验速览

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•- Signed and dated informed consent form by the subject or the subject’s legally authorized representative
•- The subject is = 4 to = 65 years of age
•- The subject has Karnofsky performance score of = 60
•- Hemophilia A and B of any severity, with documented history of high-titer inhibitor (>5BU) for at least 12 months; or, if inhibitor titer is = 5 BU, and the subject is refractory with increased dosing of either FVIII or FIX, as demonstrated from the subject’s medical history
•- Currently being treated on an on-demand basis for treatment of bleeding episodes
•- Adequate venous access, with or without central venous device
•- >/= 12 bleeding episodes requiring treatment with by-passing agents in the past 12 months, based on medical history
•- Competent in home treatment and infusion therapy
•- Currently using bypassing agents (APCCs, or rFVIIa) for treatment of bleeding episodes
•- HCV-, either by antibody testing or PCR; or HCV+ with stable hepatic disease
•- HIV-, or HIV+ with stable disease and CD4 count > 200 cells/mm3 at screening
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Currently receiving immune tolerance induction (ITI)
•- Currently on regular prophylactic therapy to prevent bleeding episodes
•- Clinically symptomatic liver disease (e.g. diagnosis of cirrhosis, [liver biopsy confirmed], portal vein hypertension, ascites, prothrombin time (PT) 5 seconds above upper limit of normal)
•- Platelet count < 100,000/ml
•- Planned elective surgery during participation in this study
•- Subject is currently participating in another clinical study and has received an investigational product or device within 30 days prior to study entry
•- Planned use of pegylated and non-pegylated alpha-interferon with or without ribavarin for HCV infected subjects or planned use of a protease inhibitor for HIV infected subjects. Subjects currently taking any of these medications for a 30-day course are eligible
•- D-dimer levels twice the upper level of normal
•- Known hypersensitivity to AICCs
•- Currently treated with a systemic immunomodulating drug
•- Prior history of thromboembolic event: acute myocardial infarction, deep vein thrombosis, pulmonary embolism
•- Diagnosis of advanced atherosclerosis, malignancy and/or other diseases that may increase the subject’s risk of thromboembolic complications
•- Clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance

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