Clinical trial - phase II - to test safety and efficay of Etravirine's treatment in Friedreich Ataxia's patients - FAEST

ASSOCIAZIONE LA NOSTRA FAMIGLIA - SEZIONE SCIENTIFICA I.R.C.C.S. E.MEDEA0 个研究点目标入组 35 人开始时间: 2021年6月1日最近更新: 2024年3月12日

适应症

试验速览

暂无简介。

•FRDA molecularly defined (expansion in at least one of the alleles of the FXN gene). • Absence of HIV infection (anti-HIV research negativity) • Ability to complete the cycle ergometer test with legs or arms to measure maximum exercise (the patient must be able to pedal at least 60 rpm without additional resistance for at least 3 minutes). • Willingness to participate in the study and sign the informed consent form. • Age range 10-40 years
•Are the trial subjects under 18? yes
•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 18
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Pregnancy or breastfeeding in place. • Known sensitivity to the ETR or to one of its excipients. • Exposure to ETR or other experimental therapies used in FRDA (eg IFNy, erythropoietin, nicotinamide, idebenone, deferiprone, etc.). • Any previous treatments with ETR should have been interrupted at least 4 months before entering the study. • Serious medical conditions that can interfere with the absorption and distribution of the drug (liver or kidney failure, severe metabolic imbalance), major heart disease (ejection fraction <40%). • Ongoing treatment with carbamazepine, phenobarbital, phenytoin, rifampicin, rifapentine, clopidogrel, hypericum. • Positivity to the HIV test

发起方

ASSOCIAZIONE LA NOSTRA FAMIGLIA - SEZIONE SCIENTIFICA I.R.C.C.S. E.MEDEA