EUCTR2006-006319-54-SK进行中（未招募）1 期
An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002
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.Previously met eligibility criteria in the previous basiliximab UC study
- •2.Completed all study visits in previous study, even if they discontinued study drug dosing before the end of the study
- •3.Must have a total Mayo score at entry to BSX-002 consistent with clinical response or clinical remission as follows:
- •-Clinical remission is defined as a total Mayo score of 2 points or less, with no individual subscore exceeding 1 point.
- •-Clinical response is defined as a decrease in total Mayo score of at least 3 points, with a decrease in rectal bleeding subscore of at least 1 point and/or an absolute rectal bleeding subscore of 0 or 1.
- •4. Signed a current IRB/IEC-approved informed consent form
- •5.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.
- •6.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.Subject discontinued blinded study drug in previous study due to a study-drug related adverse event
- •2.Subject is severely ill, as evidenced by more than 6 episodes of loose stools, all of them bloody, during a 24-hour period within the prior 7 days, 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
- •3. Subject is currently receiving a restricted/prohibited concomitant medication
- •4.Subject has undergone colectomy (total, or subtotal)
- •5. Subject has HIV infection
- •6.Subject is pregnant or breast-feeding
- •7.Prior noncompliance with previous study visit schedule and requirements
研究者
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