NL-OMON47156已完成2 期
Sirolimus for the treatment of severe intestinal polyposis in patients with familial adenomatous polyposis (FAP); a pilot study - Sirolimus and FAP
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- >= 18 years
- •-A genetically confirmed APC mutation
- •-Classical FAP phenotype (100-1000 colorectal adenomatous polyps)
- •-Subtotal colectomy with ileorectal anastomosis (IRA) or ileo-anal pouch anastomosis
- •-Severe rectal or pouch polyposis, defined as having >25 polyps amenable to complete removal (InSiGHT 2011 Staging System score of 3)
- •-Fertile patients must use effective contraception during study treatment and until 12 weeks after treatment
排除标准
- •-Inability to give informed consent
- •-Participation in another interventional clinical trial
- •-Subjects who are pregnant or breast-feeding
- •-Prior pelvic irradiation
- •-Invasive malignancy in the past 5 years
- •-Subjects who are HIV positive
- •-Subjects with severe systemic infections, current or within 2 weeks prior to study start
- •-Subjects with known severe restrictive or obstructive pulmonary disorders
- •-History of pulmonary embolism or deep venous thrombosis
- •-Major surgery less than or equal to 2 weeks prior to enrollment or any planned surgery within treatment period
- •-Active post-operative complication, e.g. infection, delayed wound healing
- •-History of hypersensitivity to sirolimus or to its excipients or drugs of similar chemical classes
- •-Regular NSAID use
- •-Use of other FAP directed drug therapies
- •-Subjects requiring systemic anticoagulation
- •-Co-medication that could interact with sirolimus: Ciclosporine, IL-2-receptorantibodies, Calcineurine inhibitors, HMG-CoA-reductase inhibitors, fibrates, CYP3A4-inhibitors (such as ketoconazol, voriconazol, itraconazol, telitromycine, claritromycine, troleandomycine, verapamil, diltiazem, erytromycine, ritonavir, indinavir, boceprevir, telapravir, nicardipine, bromocriptine, cimetidine, danazol), CYP3A4-inductors (such as rifampicine, rifabutine, St. Janskruid, carbamazepine, fenobarbital, fenytoine), ACE-inhibitors, cisapride, metoclopramide), Pgp inhibitors
- •-Use of grapefruit juice
- •-Use of attenuated vaccins;-Significant abnormalities in hepatic function
- •-Significant hematologic abnormalities
- •-Increased fasting serum cholesterol or triglyceride (whether or not on lipid-lowering therapy)
- •-Increased glucose
- •-Electrolyte abnormalities
- •-Calculated glomerular filtration rate (GFR) less than 40 mL/min/1.73m2
- •using the simplified Modification of Diet in Renal Disease (MDRD) formula
- •-Spot urine protein to creatinine ratio (UPr/Cr) greater than or equal to 0.5
研究者
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