EUCTR2008-000086-38-IT进行中（未招募）不适用
A PHASE 2, SINGLE ARM, MULTI-CENTER STUDY ON THE BENEFIT/COST/SAFETY PROFILE OF LOW-DOSE RITUXIMAB FOR REFRACTORY MIXED CRYOGLOBULINEMIA - ND
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA0 个研究点开始时间: 2008年4月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •A diagnosis of mixed cryoglobulinemia (type II or III) associated with chronic HCV infection (positive serology and/or HCV viremia). At least one of the following signs and symptoms of cryoglobulinemic vasculitis: - purpura - skin ulcer(s) - peripheral neuropathy (documented by ENG) - renal involvement (creatinine >2 mg/dl and increased BUN, and/or proteinuria >500 mg/day) - gastrointestinal involvement (vasculitis of the esophagus, stomach, small intestine, colon, or any intraabdominal viscera presenting as unexplained abdominal pain, gastrointestinal hemorrhage or intestinal ischemia) - signs & symptoms of hyperviscosity. - pulmonary involvement (pulmonary hemorrage caused by vasculitis) - severe CNS involvement (signs of active CNS vasculitis at MRI) Previous failure of anti-HCV therapy (PEG-IFN and ribavirine), relapse after response without indication to retreatment (according to the AIFA guidelines), contraindication or intolerance to anti-HCV therapy.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous treatment with rituximab Coexistence of life-threatening condition(s) unrelated to MC. A diagnosis of hematological or non-hematological malignancy. HIV or HBV positive Ongoing therapy with high dose corticosteroids and/or immunosuppressive drugs Ongoing plasmapheresis course (eligible 2 months after interruption) Any ongoing infection
研究者
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