NCT01688024Unknown2 期
Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis
Li, Zhiping, M.D.1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety of mitomycin C in the treatment of primary sclerosing cholangitis (PSC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 or older
- •Previously established diagnosis of primary sclerosing cholangitis
排除标准
- •American Society of Anesthesiologists class 4 or greater
- •Serum creatinine >= 1.7 mg/dL, eGFR <= 30 mL/min, or dialysis dependence
- •Serum hemoglobin <= 7 g
- •Left ventricular ejection fraction <= 30%
- •Dyspnea with minimal exertion (or supplemental oxygen dependence)
- •History of bone marrow disease
- •Prior recipient of organ transplantation
- •Ongoing chemotherapy
- •Obstruction of the upper GI tract
- •Pregnant or lactating
- •Inability to provide informed consent
研究组 & 干预措施
Mitomycin C
Experimental
Up to 10 mg administered during each standard of care endoscopic retrograde cholangiography. No more than five mitomycin C applications per every twelve months will be given.
干预措施: Mitomycin C (Drug)
Normal saline
Placebo Comparator
Given during each standard of care endoscopic retrograde cholangiography. No more than five normal saline applications per every twelve months will be performed.
干预措施: Normal saline (Drug)
结局指标
主要结局
Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis
时间窗: Two years
次要结局
- Number of Patients with Adverse Events(Two years)
- Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications(Two years)
研究者
研究点 (1)
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