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

St. Antonius Ziekenhuis0 个研究点目标入组 25 人开始时间: 2018年1月11日最近更新: 2018年6月5日

适应症

试验速览

暂无简介。

•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).
•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 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 13

•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 drugs that are metabolized by CYP3A: that prolongate QT-interval (mizolastine, pimozide, sertindole of quinidine), orally administered midazolam, statins (simvastatin, atorvastatin), alkaloids (ergotamine), eletriptan, or drugs that induce CYP3A4 (rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital or St John's wort (Hypericum perforatum));
•8. Patients who do not understand English or Dutch language sufficiently enough;
•9. Patients who refuse informed consent.

发起方