NL-OMON43279已完成2 期
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
Maag-, darm- en leverziekten0 个研究点目标入组 11 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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.
排除标准
- •- liver cirrhosis Child-Pugh C or acute liver failure
- •- Symptomatic cholecystolithiasis (without cholecystectomie)
- •- 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)
- •- 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
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