Efficacy of thalidomide in the treatment of severe recurrent epistaxis in hereditary hemorrhagic telangiectasia (HHT)

OSPEDALE POLICLINICO S. MATTEO0 个研究点目标入组 31 人开始时间: 2012年3月19日最近更新: 2018年2月19日

适应症

试验速览

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•- Diagnosis of HHT, according to the diagnostic criteria world-wide recognized (Curacao criteria, with severe recurrent epistaxis (grade 2-3) and refractory to mini-invasive surgical procedures. - Age > 18 years - Ability of signing written informed consent - Women of childbearing potential: declared intention not to start a pregnancy throughout the study and for four weeks following the date of the last dose of thalidomide, negative serum pregnancy test obtained within 48 hours prior to the first dose of Thalidomide, declared intention to undergo pregnancy tests periodically while on the study medication - Males with female partner of childbearing potential: declared intention not to father throughout the study and for one week following the date of the last dose of thalidomide - Estimated life expectancy must be greater than 10 months
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 11
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•- Pregnant or lactating women, or potentially fertile (both males and females) who have not agreed to avoid pregnancy during the trial period and for four weeks (females) or one week (males) following the date of the last dose of thalidomide - Neurological diseases - Psychiatric illness that would prevent granting of informed consent - Active cardiovascular disease - High risk for thromboembolic events - Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption since thalidomide capsules contain lactose

发起方

OSPEDALE POLICLINICO S. MATTEO