EUCTR2012-000792-16-HU进行中（未招募）不适用
CLINICAL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF OCTAGAM 5% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES”
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 23
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age of >= 18 years and <= 75 years.
- •2.Primary immunodeficiency syndromes with significant component hypogamma-globulinaemia or antibody deficiency.
- •3.Previously treated with a commercial IVIG
- •a) approximately every 21–28 days for at least 6 infusion intervals b) at a constant dose between 200 and 800 mg/kg body weight (+/- 20% of the mean dose for the last 6 infusions).
- •4.Availability of the IgG trough levels of the 2 previous infusions before enrolment, and maintenance of more than 5.0 g/L in the trough levels of these 2 infusions.
- •5.Negative result on a pregnancy test for women of childbearing potential and use of a reliable method of contraception for the duration of the study.
- •6.Freely given written informed consent.
- •7.Willingness to comply with all aspects of the protocol, including blood sampling, for the duration of the study.
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •8.Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to and during the screening period.
- •9.Known history of adverse reactions to IgA in other products.
- •10.Exposure to blood or any blood product or derivative, other than commercially available IVIG, within the past 3 months prior to enrolment.
- •11.Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, or any component of the investigational product.
- •12.Requirement of any routine premedication for IVIG infusion.
- •13.History of congenital impairment of pulmonary function.
- •14.Severe liver function impairment
- •15.Presence of renal function impairment, or predisposition for acute renal failure.
- •16.History of autoimmune haemolytic anaemia.
- •17.History of diabetes mellitus.
- •18.Congestive heart failure NYHA class III or IV.
- •19.Non-controlled arterial hypertension.
- •20.History of deep vein thrombosis or thrombotic complications of IVIG therapy.
- •21.Known HIV, HCV, or HBV infection.
- •22.Presence of any clinically relevant disease or unstable condition at screening, other than PID, which in the opinion of the Investigator could interfere with the conduct of the study.
- •23.Treatment with steroids , immunosuppressive or immunomodulatory drugs.
- •24.Planned vaccination during the study period except for killed” influenza vaccines (incl. H1N1).
- •25.Participating in another clinical trial or planned participation in another trial for the duration of this study.
- •26.Treatment with any investigational agent within 3 months prior to enrolment.
- •27.Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 months prior to enrolment.
- •28.Pregnant or nursing women.
- •29.Unable or unwilling to comply with the study protocol.
研究者
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