FEIBA NF: STUDIO PROSPETTICO IN APERTO, RANDOMIZZATO, A GRUPPI PARALLELI, VOLTO A VALUTARE EFFICACIA E SICUREZZA DEL TRATTAMENTO PROFILATTICO VS QUELLO AL BISOGNO IN PAZIENTI AFFETTI DA EMOFILIA A O B E CON INIBITORI A TITOLO ELEVATO - FEIBA NF Prophylaxis Study

BAXTER INNOVATIONS GMBH0 sites34 target enrollmentStarted: January 21, 2010Last updated: December 10, 2012

Conditions

Drugs

Trial Snapshot

No summary available.

•- Signed and dated informed consent form by the subject or the subjects 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 subjects 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 therosclerosis, malignancy and/or other diseases that may increase the subjects 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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