EUCTR2006-004303-19-GB进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
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
- •Subjects must satisfy all of the following inclusion criteria to be eligible for the study:
- •1.Male or female subjects, age =18 years and =75 years
- •2.Weight of 40 kg or greater
- •3.Signed a current IRB/IEC-approved informed consent form
- •4.Diagnosis of ulcerative colitis confirmed through screening endoscopy. A
- •rectal biopsy will be obtained and reviewed by a local pathologist.
- •Histopathology must be compatible with the diagnosis.
- •5.Extent of disease must involve at least the left colon (i.e., greater than 15
- •cm beyond the anal verge as the endoscope is withdrawn)
- •6.Moderate to severe disease, defined as a total Mayo score of 6 points or
- •greater, including an endoscopic subscore of 2 points or greater. Systemic
- •features of tachycardia, fever, and/or significant anemia should not be
- •7.Steroid-refractory disease, defined as moderate to severe disease,
- •without systemic features , despite treatment with prednisone 40 – 50
- •mg/day (or other oral steroid at equivalent dose) orally for a minimum of
- •14 days immediately preceding study entry
- •8.Concomitant azathioprine or 6-mercaptopurine treatment is permitted
- •during the study if initiated at least 12 weeks before study entry, and if
- •the dose has not been changed or stopped for at least 8 weeks before
- •study entry.
- •9.Concomitant oral aminosalicylate treatment is permitted during the study if
- •initiated at least 4 weeks before study entry, and if the dose has not been
- •changed or stopped during this time.
- •10.Females of childbearing potential must use an effective birth control
- •method, and be willing to continue birth control during the study, and for 4
- •months after the last dose of study drug.
- •11.Females of non-childbearing potential should be surgically sterile (bilateral
- •tubal ligation with surgery at least 6 months before study entry,
- •hysterectomy, or bilateral oophorectomy at least 2 months before study
- •entry) or post-menopausal for at least 2 years.
- •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
- •Presence of any of the following conditions will exclude the subject from eligibility for the study:
- •1.Prior treatment with basiliximab or daclizumab at any time
- •2.Prior treatment with cyclosporine, tacrolimus, methotrexate, or any anti-
- •TNF agent within 3 months before study entry
- •3.Prior treatment with parenteral corticosteroids within 14 days before
- •study entry
- •4.Initiation of azathioprine or 6-mercaptopurine treatment less than 12
- •weeks before study entry, or discontinuation or change of dose less than
- •8 weeks before study entry
- •5.Initiation of oral aminosalicylate treatment , or change of dose, or
- •discontinuation less than 4 weeks before study entry
- •6.Rectally administered medications containing corticosteroids or
- •aminosalicylates within 2 weeks before screening endoscopy
- •7.If currently taking a nonsteroidal anti-inflammatory agent (NSAID), the
- •inability to discontinue NSAID use during study participation
- •8.Intolerance or inability to continue oral corticosteroids during the trial
- •9. Stool studies that show presence of ova and parasites, significant
- •bacterial pathogens, or C. difficile toxin
- •10.Colitis that is indeterminate, suggestive of Crohn’s disease, or isolated to
- •the rectum, based on endoscopic and/or biopsy findings
- •11.Presence of toxic megacolon
- •12.Severely ill patients as evidenced by greater than 6 episodes of loose
- •stools, all of them bloody, during a 24-hour period within the screening
- •window, concurrent with any of the following systemic features:
- •-Heart rate >90 beats/min at rest
- •-Temperature >37.8 degrees C
- •-Hemoglobin <10.5 g/dL
- •13.Laboratory values as follows:
- •-Hemoglobin <8.5 g/dL
- •-WBC <3.0 x 10E9/L
- •-Neutrophils <1.5 x 10E9 /L
- •-Lymphocytes <0.5 x 10E9 /L
- •-Platelets <100 x 10E9 /L
- •-AST (SGOT) >3 times upper limit of normal
- •-ALT (SGPT) >3 times upper limit of normal
- •14.Pregnant or breast-feeding female patients
- •15.Chest radiograph abnormalities consistent with an infectious process
- •16.Known HIV, or viral Hepatitis B or C infection
- •17.History of or exposure to tuberculosis within 6 months before study entry
- •18. History of central nervous system demyelinating disorder
- •19.History of colonic dysplasia
- •20.History of malignancy during the previous 5 years or current malignancy,
- •with exception of adequately treated non-melanoma skin cancer or in situ
- •carcinoma of the cervix
- •21.History of varicella, herpes zoster, or severe viral infection within 6 weeks
- •before study entry, exposure to varicella within 21 days before study
- •entry, or vaccination with live virus within 4 weeks before study entry
- •22.Any ECG abnormalities unless approved by the Medical Monitor
- •23.Treatment with an investigational drug or device within 30 days before
- •study entry
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研究者
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