A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients with primary immunodeficiency disease (PID)

Biotest AG0 个研究点目标入组 50 人开始时间: 2005年2月4日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- primary immunodeficiency syndrome
•as congenital agammaglobulinaemia or hypogammaglobulinaemia, common variable
•immunodeficiency, severe combined immunodeficiencies, Wiskott Aldrich syndrome
•- written informed consent (signed by patient and/or legal guardian if applicable)
•- established replacement therapy with a single IVIG reference preparation
•including documentation of IgG trough levels during the previous 6 months
•- constant IVIG dose that had not changed by ±50% of the mean dose for at least 3
•months prior to study entry and had maintained IgG trough levels of >= 6 g/l
•- male or female patients (age 6 - 50 years)
•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

•- pregnancy or unreliable contraceptive measures or lactation period (women only)
•- known intolerance to immunoglobulins or comparable substances
•(e.g. vaccination reaction)
•- known intolerance to proteins of human origin
•- participation in another clinical trial within 90 days before entering the study
•or during the study and/or previous participation in this study
•- inability or lacking motivation to participate in the study
•- selective, absolute IgA deficiency
•- positive diagnostics of hepatitis B and hepatitis C
•- positive HIV test
•- acquired medical condition known to cause secondary immune deficiency
•such as CLL, lymphoma, multiple myeloma

发起方