EFFICACY AND SAFETY OF FACTOR IX (FIX) CONTAINED IN ALPHANINE® AND ITS PHARMACOKINETIC COMPARISON WITH BENEFIX® IN PATIENTS WITH SEVERE HEREDITARY HAEMOPHILIA B (Follow-up study of the trial IG404: EFFICACY AND SAFETY OF FACTOR IX (FIX) CONTAINED IN ALPHANINE IN PATIENTS WITH SEVERE HEREDITARY HAEMOPHILIA B)

Grifols Biologicals Inc.0 个研究点开始时间: 2008年6月19日最近更新: 2013年1月7日

适应症

试验速览

暂无简介。

•patients having participated in the previous study Efficacy and safety of factor IX (FIX) contained in ALPHANINE® in patients with severe hereditary haemophilia B”
•Are the trial subjects under 18? no
•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

•Patients will be deemed ineligible if they:
•have received a dose of FIX in the 7 days previous to the infusion
•have a FIX inhibitor level of >0.5 Bethesda units or clinically relevant presence in the past (>5 BU),
•have active bleeding at that moment of infusion,
•CD4 lymphocyte count < 400/?l,
•have known allergic reaction to any Benefix® component,
•exhibits symptoms of any intercurrent infection (i.e. fever, chills, nausea, etc.) at the time of the first infusion,
•have any disease that might affect the distribution or metabolism of FIX and which could affect interpretation of the study (such as non-controlled diabetes mellitus),
•have non-controlled arterial hypertension,
•have abnormal renal function (creatinine >1.5 mg/dl),
•have documented liver cirrhosis or any hepatic disorder with ALT levels 2.5 times or more than the normal upper limit,
•are simultaneously participating in other clinical studies,
•prevision to be concomitantly treated with other FIX-containing products,
•have conditions that might affect patient compliance (survival-limiting [in 2 year time] diseases, alcohol or other drug abuse, etc.),
•any patient unable to provide a storage plasma sample before the first dose of Benefix®.

发起方