EUCTR2005-003482-17-IT进行中（未招募）不适用
A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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 Males and females, 18 years of age or older.2 Diagnosis of UC verified by colonoscopy or barium enema performed within 36 months prior to consent.3 Severe active disease, as defined by a Modified Truelove Witts Severity Index MTWSI; also known as Lichtiger Score 11 at consent, with a confirmatory MTWSI 10 on or after the fifth consecutive day of IV steroids and within 1 day prior to randomization.4 Mayo score 10 and Mayo mucosal subscore 2 after a minimum of 3 consecutive days ie, on or after the fourth consecutive day of IV steroids. 5 Adequate contraception from the day of consent through 3 months after the last dose of study drug. 6 Negative serum pregnancy test at screening.7 Negative Clostridium difficile test within 10 days prior to randomization. 8 Signed and dated informed consent and HIPAA if applicable.
- •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
- •1 UC requiring immediate intervention.2 History of prior colorectal surgery or ileostomy.3 White blood cell count less than 2.5 x 103/mcL; platelet count less than 150 x 103/mcL; or hemoglobin level less than 8 g/dL.4 Medically significant infections, particularly those of viral etiology. This includes any incidence of opportunistic infections within the past 12 months.5 Live vaccination within 6 weeks prior to randomization. 6 History of deep vein thrombosis or pulmonary embolus. 7 Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality. 8 History of lymphoproliferative disorder LPD or malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix that has been adequately treated. 9 Seropositivity for infection with human immunodeficiency virus HIV-1 , hepatitis B virus HBV surface antigen, or hepatitis C virus HCV .10 Pregnancy or nursing.11 Infliximab-treated subjects may not receive study drug until 4 weeks after their first dose or 2 weeks after a subsequent dose of infliximab. 12 Treatment with cyclosporine or tacrolimus FK506 within 2 weeks prior to randomization.13 Treatment with any other investigational drugs or therapies within 60 days prior to randomization. 14 Initiation or increase of dosing of 6 mercaptopurine, azathioprine, or methotrexate within 60 days immediately prior to randomization. 15 Failure to discontinue any UC drug including, but not limited to 6 mercaptopurine, azathioprine, or methotrexate , except glucocorticoids or 5-ASA, prior to randomization.16 Nontherapeutic levels of chronic antiseizure medications in subjects with a prior history of seizures. 17 Any condition that, in the investigator s opinion, makes the subject unsuitable for study participation.
研究者
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