EUCTR2005-003482-17-GR进行中（未招募）不适用
A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ D
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
- •Eligible subjects will be considered for inclusion in theis study if they meet all of the following criteria:
- •1) Males & females, 18 years of age or older.
- •2) Diagnosis of UC, as verified by endoscopy performed within 60 months prior to consent.
- •3) Severe active disease, as defined by MTWSI =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/registration.
- •4) Mayo score =10 and a Mayo mucosal subscore (finding of flexible proctosigmoidoscopy) of =2. The Mayo score will be calculated on the day of sigmoidoscopy by a blinded gastroenterologist, after a minium of 3 consecutive days (i.e. on or after the fourth consecutive day) of IV steroids.
- •5) 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.
- •6) Negative serum pregnancy test at screening in female subjects of childbearing potential.
- •7) Negative Clostridium difficile test within 10 days prior to the first dose of study drug.
- •8) Ability to understanding the purpose and risks of the study and provide signed and dated informed consent.
- •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) History of total proctocolectomy, or subtotal colectomy with ileorectal anastomosis.
- •3) Presence of ileostomy.
- •4) White blood cell count less than 2.5 x 10 (E3)/mcL; platlet count less than 150 x 10 (E3)/mcL; or hemoglobin level less than 8g/dL. Note the following exceptions for WBC counts only (minimum platelet counts and hemoglobin levels are the same)
- •a) If subject is currently taking a stable dose of 6MP/AZA for 60 days or more, a WBC count <2.0 x 10 (E3)/mcL.
- •b) If subject has initiated treatment with, or increased his/her dose of, 6MP, AZA or methotrexate (MTX) within 60 days prior to consent, a WBC count of = 5 x 10 (E3)/mcL at the time of screening.
- •5) Active medically significant infections, particularly those of viral etiology, e.g. known CMV colitis. This includes any incidence of medically significant opportunistic infections(see Definitions) within the past 12 months.
- •6) Live vaccination within 6 weeks prior to randomization (Subjects may not receive any vaccine for 60 days after randomization).
- •7) Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality (e.g. creatinine =1.6 mg/dL; ALT or AST = 2X the upper limit of normal [ULN]; alkaline phosphatase = 1.5X ULN); a history of myocardial infarction, coronary artery disease, congestive heart failure, or arrhythmias within 6 months prior to consent.
- •8) History or treatment of lymphoproliferative disorder (LPD) or malignancy within the past 5 years (excluding nonmelanoma skin cancer or carcinoma in situ of the cervix).
- •9) Seropositive for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV) antibody.
- •10) Treatment with a first dose of infliximab or another anti-TNF- a drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF-a drug within 2 weeks of randomization.
- •11) Treatment with cyclosporine or tacrolimus (FK506) within 2 weeks prior to randomization.
- •12) Treatment with any other investigational drug or therapy within 60 days prior to randomization, except those mentioned in the above two exclusion criteria.
- •13) Any condition that, in the investigator’s opinion, makes the subject unsuitable for study participation.
- •14) Unable or unwilling to discontinue all UC drugs, except for glucocorticoids and oral 5-ASA, immediately prior to randomization.
- •15) Pregnancy or nursing.
- •16) Nontherapeutic levels of chronic anti-seizure medications in subjects with a prior history of seizures, as tested within 4 days prior to randomization.
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