NCT00366925已完成不适用
Randomized Controlled Multicenter Investigation to Compare the Efficacy and Safety of Adacolumn® Granulocytes, Monocytes/Macrophage Apheresis Device, 5 Versus 10 Treatments, in Patients With Active Ulcerative Colitis
Otsuka Frankfurt Research Institute GmbH2 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2006年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of 5 Adacolumn® treatments over 5 weeks to 10 treatments (two Adacolumn® apheresis treatments during the first 2 weeks, followed by 6 weeks with one Adacolumn® apheresis treatment) in patients with active ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old
- •Active ulcerative colitis documented by clinical symptoms, endoscopic findings and histology (in patient history)
- •Moderate to severe active ulcerative colitis at baseline evaluation, defined as follows:
- •Clinical activity idex (CAI) score > 6; and
- •Stool frequency score of 2 or 3
- •Colonic involvement with ulcerative colitis beyond 15 cm of the anal verge
- •Ulcerative colitis for at least 3 months
- •Adequate peripheral venous access to allow for completion of the apheresis treatments, as demonstrated by the ability to successfully undergo a brief venous access procedure
- •Receiving one or more of the following medical therapies:
- •Sulfasalazine, mesalamine and other 5-aminosalicylic acid (5-ASA) agents for 4 weeks or more with a stable dose for the last 2 weeks
- •A maximum of 20 mg per day of prednisone with a stable dose for the last 2 weeks, or
- •6-mercaptopurine or azathioprine for 12 weeks or more with a stable dose for the last 4 weeks; OR
- •Have not received the above medical therapies due to intolerance or demonstrated non-response for the time periods specified below:
- •Sulfasalazine, mesalamine and other 5-ASA agents for 2 weeks
- •Prednisone for 2 weeks, or
- •6-mercaptopurine or azathioprine for 4 weeks
- •For female subjects of child-bearing potential, a negative pregnancy test and agreement to use an effective contraceptive method or abstain from sexual intercourse during the course of the clinical investigation
- •Agree to participate in the required follow-up visits
- •Able to complete the diary
- •Signed written informed consent document
排除标准
- •Febrile (> 38ºC)
- •Evidence of toxic megacolon
- •Anticipated need for surgery within 12 weeks
- •Known obstructive diseases of the gastrointestinal system
- •Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
- •A history of allergic reaction to heparin or heparin-induced thrombocytopenia
- •A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
- •Requires a central venous access catheter for the apheresis treatments
- •Known infection with enteric pathogens, pathogenic ova or parasites, or a positive assay for C. difficile toxin
- •Hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 65 mmHg) at screening visit only
- •Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 120 mmHg) despite medical therapy at screening visit only
- •A history of myocardial infarction or unstable angina within the past 6 months
- •A history of coronary artery bypass grafting surgery or angioplasty within the past 6 months
- •A history of physical findings compatible with a cerebrovascular accident
- •Congestive heart failure (New York Heart Association Class III or IV)
- •Prosthetic heart valve, pacemaker or other permanent implant
- •Severe cardiovascular or peripheral vascular disease
- •Liver disease defined as levels of SGOT [AST], SGPT [ALT] or alkaline phosphatase > 2.5x the upper limit of the normal range for the laboratory performing test
- •History of cirrhosis
- •Renal insufficiency, defined as serum creatinine > 150% of the upper limit of the normal range for the laboratory performing the test
- •Insulin-dependent type I or type II diabetes. (Patients receiving oral antidiabetic treatment can be included.)
- •Known bleeding disorder (PT or PTT > 1.5x the upper limit of the normal range for the laboratory performing the test), or concomitant anticoagulant therapy for purposes other than apheresis treatment
- •Prior history suggestive of a hypercoagulable disorder, including 1 or more episodes of pulmonary embolism or deep vein thrombosis
- •Known infection with hepatitis B or C, or HIV
- •Abnormal hematology parameters defined as severe anemia with hemoglobin < 8.5 g/dL, white blood cell count of < 3,500/ul and a granulocyte count < 2,000/μl
- •Fibrinogen level > 700 mg/dL
- •Major surgery within the past 6 weeks
- •Active infections less than 4 weeks from successful completion of antibiotic treatment for routine bacterial infection
- •Febrile viral infection within 4 weeks of entry into the clinical investigation
- •Less than 12 weeks from conclusion of therapy for systemic fungal infections
- •Malignancy within the past 2 years other than surgically cured skin carcinoma or cervical dysplasia (CIN I-II)
- •History of dysplasia or carcinoma of the colon
- •Current drug or alcohol abuse
- •Pregnant, lactating or planning to become pregnant during the course of the clinical investigation
- •Used within the last 30 days, an investigational drug, biologic or device or 5 half lives, if known, for any investigational drug or biologic
- •Received cyclosporine or tacrolimus within the last 4 weeks
- •Received infliximab within the last 8 weeks
- •Received oral budesonide within the last 2 weeks
- •Used topical therapy for ulcerative colitis within the last 2 weeks
- •Previously received Adacolumn® treatments
研究者
研究点 (2)
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