EUCTR2005-003481-42-IT进行中（未招募）不适用
A Randomized, Double-Blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
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)Only 1 prior treatment course with visilizumab (or placebo in a blinded visilizumab study). 3)Response (as defined in parent protocol) of IVSR-UC disease to visilizumab or placebo. 4)Active disease at screening, and symptomatic worsening, defined as an increase of >=3 points from the subject's best MTWSI response, and a score of >=9, sustained for at least 2 assessments, performed at least 1 week apart; and a confirmatory MTWSI >=8 within 1 day prior to randomization. 5)CD3+4+ T-cell count >=200 cells/mcL at screening for this protocol, or >=80% of the subject's screening baseline count prior to enrollment on the parent study. 6)Mayo assessment (including flexible sigmoidoscopy) performed by a trained, blinded evaluating physician within 2 weeks prior to randomization. 7)Adequate contraception from the day of consent through 3 months after the last dose of study drug. 8)Negative serum pregnancy test at screening. 9)Negative Clostridium difficile test within 10 days prior to randomization. 10)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 surgical, endoscopic, or radiologic interventions. 2)White blood cell count less than 2.5 x 103 /mcL; platelet count less than 150 x 103/mcL; or hemoglobin less than 8 g/dL. 3)Active medically significant infections, particularly those of viral etiology, eg, known CMV colitis. This includes any incidence of opportunistic infections within the past 12 months. 4)Live vaccination within 6 weeks prior to randomization. 5)History of deep vein thrombophlebitis or pulmonary embolus. 6)Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality. 7)History of lymphoproliferative disorder (LPD) or malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix that has been adequately treated. 8)Seropositive for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV). 9)Pregnancy or nursing. 10)Treatment with any other UC salvage drugs (including but not limited to infliximab, cyclosporine, tacrolimus [FK506], adalamumab, and thalidomide) or therapies (surgery, pheresis, affinity columns) since the first course of treatment with study drug in the parent visilizumab study. 11)Treatment with any other investigational drug or therapy within 60 days prior to randomization. 12)Nontherapeutic levels of chronic antiseizure medications in subjects with a history of seizures. 13)Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.
研究者
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