EUCTR2004-004388-31-DE进行中（未招募）不适用
A Phase IIa, Open-label Study of Visilizumab in Patients with Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn’s Disease - N/A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
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 patients will be considered for inclusion in this study if they meet all of the following criteria:
- •1) Male or female, 18 to 70 years of age
- •2) A diagnosis of CD and at least one documented external, draining, perianal fistula
- •3) Patients with reproductive potential who agree to use double-barrier methods of contraception during the study and for 3 months after receiving study drug
- •4) Women of childbearing potential who have a negative serum pregnancy test
- •5) Who have tested negative for C difficile within 3 weeks prior to treatment with study drug
- •6) Who are capable of understanding the purpose and risks of the study and who provide signed and dated informed consent and an authorization to use protected health information (US sites only)
- •7) Who have EBV DNA titers up to 30, 000 copies/mL
- •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
- •Patients will be ineligible for this study if they meet any one of the following criteria:
- •1) History of lymphoproliferative disorder or a prior malignancy within 5 years or current malignancies (excluding nonmelanoma skin cancer or carcinoma in situ of the cervix that has been adequately treated)
- •2) Pregnant women or nursing mothers
- •3) Any of the following hematologic abnormalities: WBC < 2500/mm3; platelets < 150,000/mm3; hemoglobin < 10 g/dL
- •4) Serologic evidence of infection with human immunodeficiency virus (HIV) or hepatitis B or C virus (HBV, HCV)
- •5) Presence of obstructive symptoms, confirmed by endoscopy showing an impassable stricture or computed tomography (CT) or barium studies showing stricture with prestenotic bowel dilation, within 6 months prior to receiving study drug
- •6) Likely to require surgery in the next 6 months, such as those with clinically apparent abscesses or severely symptomatic stenoses (patients with fistula abscesses and/or setons at screen may be eligible for study entry if abscesses can be drained before patients receive study drug
- •7) Serious infections, particularly those of viral etiology, eg, active CMV colitis, and who have history of opportunistic infections within the past year
- •8) Active infections that require antibiotic therapy (not to include use of antibiotics to control CD)
- •9) Serious infections that required IV antibiotic therapy or hospitalization within 8 weeks prior to receiving study drug
- •10) Started, or have had a dose change of, sulfasalazine, 5-aminosalicylic acid (5-ASA), or antibiotics, probiotics or topical therapies for CD within 2 weeks prior to receiving study drug
- •11) Had an increased dose change in corticosteroid medication 2 weeks prior to receiving study drug; is receiving IV steroids; or, is receiving a daily dose of > 40 mg prednisone, > 9 mg budesonide, or equivalent
- •12) Received a live vaccine within 6 weeks prior to receiving study drug (patients may not receive a live vaccine during treatment or for 12 weeks after treatment with study drug)
- •13) Received any monoclonal antibodies (including infliximab) or investigational agents or biologics within 3 months prior to receiving study drug
- •14) Received cyclosporine or tacrolimus (FK506) within 4 weeks of receiving study drug
- •15) Had a dose change of or discontinued from 6-mercaptopurine, azathioprine, or methotrexate within 4 weeks prior to receiving study drug
- •16) Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, non-CD-related gastrointestinal, endocrine, or metabolic (eg, creatinine >= 1.6 mg/dL; ALT or AST >= twice the upper limit of normal (ULN); alkaline phosphatase >= 1.5 X ULN; history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry)
- •17) History of lymphoproliferative disorder
- •18) History of tuberculosis (TB) or other mycobacteria infection, or chest x-ray positive for previous TB infection
- •19) History of thrombophlebitis or pulmonary embolus
- •20) Histories of immune deficiency or autoimmune disorders other than CD (not including joint, skin, hepatic, and ocular inflammatory conditions that may be more typically associated with CD)
- •21) History of seizure with subtherapeutic blood levels of anticonvulsive medications (documented) within one week before study enrollment
研究者
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