Double-blind, Randomized clinical study of GGS (Intravenous Immunoglobulin) in patients with CSS/AGA. Phase 3 study.

TEIJIN PHARMA LIMITED0 个研究点目标入组 21 人开始时间: 2006年5月2日最近更新: 2023年10月17日

适应症

试验速览

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•Patients with CSS/AGA associated with neuropathy responding poorly to traditional therapy (steroid therapy, etc.)
•Main Inclusion Criteria
•1.Patients with a diagnosis of definite CSS/AGA according to Diagnostic criteria for allergic granulomatosus angiitis (Churg-Strauss Syndrome) proposed by the Research Committee of Intractable Vasculitis, Ministry of Health and Welfare, Japan (1998)
•2.Patients who have underwent the following steroid therapy for CSS/AGA
•A:Treatment with corticosteroid at 40 mg/day as prednisolone for at least 4 weeks as remission induction therapy
•B:After the tapering following A, treatment with corticosteroid at a constant dose of 5 mg/day or higher and 20 mg/day or lower as prednisolone for at least 4 weeks
•3.Patients who have at least one impaired site with a manual muscle testing (MMT) score of not more than 3 and have a MMT sum score of not more than 130

•Main Exclusion Criteria
•1.Patients with a history of shock or hypersensitivity to any human immunoglobulin preparation
•2.Patients with IgA deficiency
•3.Patients with serious renal disorder
•4.Patients with cerebrovascular or cardiovascular disorder or its history
•5.Patients with a high risk of thromboembolism
•6.Patients with hemolytic/blood loss anemia
•7.Patients with reduced cardiac function
•8.Patients with immunodeficiency or under immunosuppression
•9.Pregnant, potentially pregnant, or lactating patients
•10.Patients who are being treated in other clinical study or who complete other clinical study within the last 4 weeks

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