NL-OMON48255已完成2 期
An uncontrolled, open label pilot-study assessing the efficacy in reducing bleeding severity, and the safety of oral tacrolimus in patients with hereditary hemorrhagic telangiectasia - Tacrolimus for bleeding in HHT patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
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
- •* Patients with HHT:
- •o Definite HHT according to the Curacao criteria (3 positive criteria or more)
- •o Genetically confirmed HHT
- •* Suffering from epistaxis at least on average of 4 days per week or documented
- •gastrointestinal teleangiectasis by endoscopy with suspicion of bleeding;
- •* In the last six months suffering from anemia, iron deficiency or use iron
- •treatment or blood transfusions;
- •* Failure or partial failure of local treatment with systemic treatment
- •indicated by ENT specialist or gastroenterologist;
- •* Adult (18 years or older at time of inclusion).
排除标准
- •* Hypersensitivity or allergy for tacrolimus
- •* Patients with a severe disease with a life-expectancy <1 year;
- •* Women that are pregnant, nursing, have a pregnancy wish in the study period
- •or who use anticonception inadequately;
- •* Patients currently receiving chemotherapy;
- •* Severe kidney disease
- •* History of severe ventricular cardiac dysfunction
- •* A negative advise of a clinical pharmacist in cases with concurrent use of
- •drugs that have a clinically relevant interaction with tacrolimus.
- •* Patients who do not understand English or Dutch language sufficiently enough;
- •* Patients who refuse informed consent.
研究者
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