EUCTR2005-003481-42-SK进行中（未招募）1 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
Protein Design Labs, Inc0 个研究点目标入组 80 人开始时间: 2005年11月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- •Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
- •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 of =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) Agreement to use adequate contraception by male or female subjects of reproductive potential throughout the study and for 3 months after receiving the last dose of study drug
- •8) Negative serum pregnancy test at screening in female subjects of childbearing potential
- •9) Negative Clostridium difficile test within 10 days prior to the first dose of study drug
- •10) Ability to understand the purpose and risks of the study and provide signed and dated informed consent. For US sites only, subjects must also provide an authorization to use protected health information (in accordance with the Health Insurance Portability and Accountability Act or HIPAA in the US)
- •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
- •Subjects will be ineligible for this study if they meet any one of the following criteria:
- •1) UC requiring immediate surgical, endoscopic, or radiologic interventions, including massive hemorrhage, perforation and sepsis, suppurative complications (intra-abdominal or perianal abscesses), or toxic megacolon requiring imminent intervention
- •2) 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
- •3) Active medically significant infections, particularly those of viral etiology, eg, known CMV colitis. This includes any incidence of medically significant, opportunistic infections (see Definitions) within the past 12 months
- •4) Live vaccination within 6 weeks prior to randomization. (Subjects may not receive a live vaccine during dosing or for 60 days after receiving the last dose of study drug)
- •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 (eg, creatinine =1.6 mg/dL; ALT or AST =1.5X the upper limit of normal [ULN]; alkaline phosphatase =1.5X ULN); history of myocardial infarction, coronary artery disease, congestive heart failure, or arrhythmias within 6 months prior to consent
- •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) Pregnant women or nursing mothers
- •10) Treatment with any other UC salvage drugs (including but not limited to infliximab, 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
- •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, as tested within 4 days prior to randomization
- •13) Any condition that, in the investigator’s opinion, makes the subject unsuitable for study participation
研究者
相似试验
进行中（未招募）
不适用
A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ RIntravenous steroid-refractory ulcerative colitis (IVSR-UC)MedDRA version: 9.0Level: LLTClassification code 10045365EUCTR2005-003481-42-GRPDL BioPharma, Inc.80
进行中（未招募）
1 期
A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEUCTR2005-003481-42-IEPDL BioPharma, Inc80
进行中（未招募）
不适用
A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ REUCTR2005-003481-42-HUPDL BioPharma, Inc.80
进行中（未招募）
不适用
A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyIntravenous steroid-refractory ulcerative colitis (IVSR-UC)EUCTR2005-003481-42-ATProtein Design Labs, Inc80
进行中（未招募）
不适用
A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEstudio aleatorizado, doble ciego y multicéntrico de Visilizumab frente a placebo en sujetos con colitis ulcerosa refractaria a esteroides intravenosos que hayan respondido previamente en un estudio con Visilizumab.Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Colitis ulcerosa refractaria a esteróides intravenonsosMedDRA version: 8.0Level: LLTClassification code 10045265EUCTR2005-003481-42-ESPDL BioPharma, Inc80