Prospective, open-label, non-controlled, multicenter, phase III clinical study to evaluate the pharmacokinetics, safety and efficacy of Octagam 5% in patients with Primary Immunodeficiency Diseases

Octapharma (Switzerland)0 个研究点目标入组 23 人开始时间: 2012年10月15日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Age between 18 years and 75 years
•2. Primary immunodeficiency syndromes with significant component hypogamma-globulinaemia or antibody deficiency
•3. Previously treated with a commercial IVIG every 21?28 days for at least 6 infusion intervals at a constant dose between 200 and 800 mg/kg body weight
•4. Availability of the IgG trough levels of the 2 previous infusions before enrolment

•1. Acute infection
•2. Known history of adverse reactions to IgA in other products
•3. Exposure to blood or any blood product, other than commercially available IVIG, within the past 3 months prior to enrolment
•4. Congestive heart failure NYHA class III or IV
•5. Non-controlled arterial hypertension
•6. History of deep vein thrombosis
•7. Known HIV, HCV, or HBV infection

发起方

Octapharma (Switzerland)