Sirolimus for the treatment of severe intestinal polyposis in patients with familial adenomatous polyposis (FAP); a pilot study - Sirolimus and FAP

未提供0 个研究点目标入组 5 人开始时间: 2015年12月16日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•- = 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
•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 5
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-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 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
•-Significant abnormalities in hepatic function
•-Significant hematologic abnormalities
•-Increased fasting serum cholesterol or triglyceride (whether or not on lipid-lowering therapy)
•-Increased glucose (venous, fasting): >6.4 mmol/L
•-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

发起方

未提供