An uncontrolled, pilot-study assessing the efficacy of octreotide LAR to decrease transfusion requirements and endoscopy frequency in patients with Rendu-Osler-Weber and gastrointestinal bleeding - ROW

Radboud University Medical Center0 个研究点开始时间: 2016年7月11日最近更新: 2016年8月8日

试验速览

暂无简介。

•-Patients with Rendu-Osler-Weber
•-Symptomatic gastrointestinal bleeds out of telangiectasias
•-Transfusion and / or endoscopy dependent:
•Transfusion: at least 2 blood and/or iron infusions in the 6 months before inclusion.
•Endoscopy: at least one endoscopy with APC after the initial endoscopic treatment after diagnosis in the half year before inclusion or unsuitable for endoscopy.
•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 13
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•-liver cirrhosis Child-Pugh C or acute liver failure
•-previous unsuccessful treatment with somatostatin analogues for the same indication (refractory anaemia due to telangiectasias) or current effective treatment with a somatostatin analogue
•-current successful treatment with thalidomide
•-severe diseases with life expectancy < 1 year
•-patients with left ventricular assist devices (LVAD’s)
•-Symptomatic cholecystolithiasis (without cholecystectomie)
•-pregnancy or nursing women or women who have a pregnancy wish in the studyperiod or who use anticonception inadequate
•-current chemotherapy
•-patients with a known hypersensitivity to SST analogues or any component of the pasireotide LAR formulations
•-systemic cancer currently undergoing chemotherapy or radiation therapy
•-no understanding of Dutch or English

发起方