EUCTR2019-003585-40-NL进行中（未招募）1 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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
入选标准
- •Patients with HHT:
- •oDefinite HHT according to the Curacao criteria (3 positive criteria or more)
- •oGenetically 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).
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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;
- •Patients receiving drugs that are contraindicated when using tacrolimus (see chapter 14.1, section G).
- •Patients who do not understand English or Dutch language sufficiently enough;
- •Patients who refuse informed consent.
研究者
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