EUCTR2012-000792-16-DE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”
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
相似试验
进行中（未招募）
不适用
Study to evaluate the efficacy, metabolism and safety of human immuneglobulin in patients with primary immunodeficiency diseasesprimary immunodeficiency disease (PID)MedDRA version: 14.1Level: LLTClassification code 10049485Term: Bruton's agammaglobulinemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 14.1Level: LLTClassification code 10010112Term: Common variable immunodeficiencySystem Organ Class: 10021428 - Immune system disordersEUCTR2012-000792-16-HUOCTAPHARMA AG23
进行中（未招募）
不适用
Study to evaluate the efficacy, metabolism and safety of human immuneglobulin in patients with primary immunodeficiency diseasesprimary immunodeficiency disease (PID)MedDRA version: 14.1Level: LLTClassification code 10049485Term: Bruton's agammaglobulinemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 14.1Level: LLTClassification code 10010112Term: Common variable immunodeficiencySystem Organ Class: 10021428 - Immune system disordersEUCTR2012-000792-16-CZOCTAPHARMA AG23
已完成
2 期
Effect of medicated enenma on arthritisCTRI/2012/07/002794IPGT and RA60
进行中（未招募）
不适用
CLINICAL AND PHARMACOLOGICAL STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®)PARKINSON'S DISEASEEUCTR2012-001245-40-IT
招募中
不适用
Clinical pharmacology study to evaluate the pharmacokinetics, safety and efficacy of multi-targetted tyrosine kinase inhibitor regorafenib in Japanese patients with advanced colorectal cancer.Colorectal CancerJPRN-UMIN000013939Showa University School of Medicine100