NCT00279435终止2 期
A Randomized, Double-blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
Facet Biotech0 个研究点目标入组 25 人开始时间: 2006年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
研究概览
简要总结
The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.
详细描述
The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 18 years of age or older.
- •Only 1 prior treatment course with visilizumab (or placebo in a blinded visilizumab study).
- •Response (as defined in parent protocol) of intravenous steroid-refractory ulcerative colitis (IVSR-UC) disease to visilizumab or placebo.
- •Symptomatic worsening (ie, an increase of ≥3 points in MTWSI score) from the subject's best response on the parent study, an MTWSI 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.
- •CD4^+ 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.
- •Mayo assessment (including flexible sigmoidoscopy) performed by a trained, blinded evaluating physician within 2 weeks prior to randomization.
- •Adequate contraception from the day of consent through 3 months after the last dose of study drug.
- •Negative serum pregnancy test.
- •Negative Clostridium difficile test.
- •Signed and dated informed consent, and Health Insurance Portability and Accountability Act (HIPAA) if applicable.
排除标准
- •UC requiring immediate surgical, endoscopic, or radiologic interventions.
- •White blood cell count less than 2.5 x 10^3/mcL; platelet count less than 150 x 10^3/mcL; or hemoglobin less than 8 g/dL.
- •Active, medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of opportunistic infections within the past 12 months.
- •Live vaccination within 6 weeks prior to randomization.
- •Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality, history of myocardial infarction, coronary artery disease, congestive heart failure, or arrhythmias within 6 months prior to consent.
- •History of lymphoproliferative disorder (LPD) or malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix that has been adequately treated within the past five years.
- •Seropositive for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV).
- •Pregnancy or nursing.
- •Treatment with any other UC salvage drugs (including but not limited to infliximab or another anti-TNF-a drug, cyclosporine, tacrolimus [FK506], adalimumab, thalidomide, or another experimental agent), or therapies (surgery, pheresis, affinity columns) since the first course of treatment with study drug in the parent visilizumab study.
- •Treatment with any other investigational drug or therapy within 60 days prior to randomization.
- •Nontherapeutic levels of chronic antiseizure medications in subjects with a history of seizures.
- •Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: visilizumab (Drug)
visilizumab
Experimental
干预措施: visilizumab (Drug)
研究者
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