Efficacy and safety of oral itraconazole in the reduction of epistaxis severity in hereditary hemorrhagic telangiectasia - Itraconazole for epistaxis in HHT patients

Sint Antonius Ziekenhuis0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月15日

适应症

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•1. Patients with HHT: Definite HHT according to the Curacao criteria (3 positive criteria or more) AND/OR genetically confirmed HHT
•2. Suffering from epistaxis at least on average of 4 days per week;
•3. In the last six months suffering from anemia or iron deficiency or in last twelve months use iron treatment or blood transfusions;
•4. Failure or partial failure of local treatment with systemic treatment indicated by ENT specialist;
•5. Adult (18 years or older at time of inclusion).

•1. Patients with any history of ventricular cardiac dysfunction;
•2. Patients with elevated liver enzymes or any pre-existing liver disease or a history with known liver toxicity caused by medication;
•3. Hypersensitivity or allergy for azole antifungal drugs;
•4. Patients with a severe disease with a life-expectancy <1 year;
•5. Women that are pregnant, nursing, have a pregnancy wish in the study period or who use anticonception inadequately;
•6. Patients currently receiving chemotherapy;
•7. Patients receiving drugscontraindicated when using itraconazole (see protocol chapter 14.1 section G of the study protocol for a full list)
•8. Patients who do not understand English or Dutch language sufficiently enough;
•9. Patients who refuse informed consent.

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