ISRCTN94152325已完成不适用
A phase I/II, partially randomised, open-labelled study of visilizumab in patients with severe ulcerative colitis refractory to intravenous corticosteroids
PDL BioPharma Inc. (USA)0 个研究点目标入组 144 人开始时间: 2006年2月20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
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. 18 to 70 years of age
- •2. A diagnosis of UC verified by colonoscopy or barium enema performed within 36 months prior to study entry
- •3. For first time therapy with visilizumab, active disease documented by a Modified Truelove and Witts Severity Index (MTWSI) score of 11 to 21 despite a course of intravenous (IV) steroids that occurred within 60 days prior to study day one and lasted at least five days. Patients who undergo re-treatment with visilizumab must meet the same MTWSI score requirement but need not to have failed IV steroids before re-treatment
- •4. If patient is a male or female of reproductive potential, he or she must agree to use adequate contraception during the study and for three months after receiving visilizumab
- •5. For women of childbearing potential, a negative serum pregnancy test at baseline screening
- •6. Patients must have been tested negative for Clostridium difficile within 10 days prior to treatment with visilizumab
- •7. Patients who are capable of understanding the purpose and risks of the study and who provide a signed and dated informed consent. For US sites only, patients must also provide an authorisation to use protected health information.
排除标准
- •1. Ulcerative colitis (UC) requiring immediate surgical, endoscopic, or radiologic interventions, including massive haemorrhage, perforation and sepsis, suppurative complications (intra-abdominal or perianal abscesses) or toxic megacolon
- •2. History of total proctocolectomy, or subtotal colectomy with ileorectal anastomosis
- •3. Presence of ileostomy
- •4. White blood cell count less than 2.5 x 10^3/µl, platelet count less than 150 x 10^3µl, or haemoglobin less than 8 g/dl
- •5. Patients with serious infections, particularly those of viral etiology, e.g. active cytomegalovirus (CMV) colitis. This includes any incidence of opportunistic infections within the past year.
- •6. Patients who have received a live vaccine within six weeks prior to study entry (patients may not receive a live vaccine during treatment or for six weeks after treatment with visilizumab)
- •7. Patients with a history of thrombophlebitis or pulmonary embolus
- •8. Significant organ dysfunction including: cardiac, renal, liver, central nervous system, pulmonary, vascular, gastrointestinal endocrine or metabolic dysfunction (e.g. creatinine greater than 1.6 mg/dl, or alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase greater than 1.5 x upper limit of normal) or history of coronary artery disease within six months prior to study entry
- •9. Patients with a history of lymphoproliferative disorder (LPD) or malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix that has been adequately treated
- •10. Pregnant women or nursing mothers
- •11. Seropositive for infection with human immunodeficiency virus-1 (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HBC) antibody
- •12. An Epstein-Barr virus (EBV) deoxyribonucleic acid (DNA) load greater than 5000 copies/ml in stage 1 and greater than 30,000 copies/ml in stage 2
- •13. Treatment with any investigational drugs or therapies within 60 days prior to study entry
- •14. Treatment with an antibody therapy within 60 days prior to study entry
- •15. Treatment with cyclosporine or tacrolimus (FK506) within three months prior to study entry
- •16. All of the following: a history of seizures, a history of both chronic and current treatment with anticonvulsant medication, and no documentation of therapeutic blood levels of anticonvulsant medication within seven days before study enrolment
研究者
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