Acetylcysteine in patients with Sickle Cell Disease: Reducing the incidence of daily life pain in patients with sickle cell disease - NAC Trial

Academic Medical Center0 个研究点目标入组 140 人开始时间: 2013年3月21日最近更新: 2016年9月26日

适应症

试验速览

暂无简介。

•-Age 12 years or older
•-Sickle cell disease, either homozygous sickle cell disease (HbSS), HbSC sickle cell
•disease, HbSß0 or HbSß+ thalassemia.
•Genotype needs to be confirmed by high performance liquid chromatography.
•-History of at least 1.0 painful crisis per year in the past 3 years.
•A crisis will be defined here as a patient defined, painful, sickle cell related episode of at least 24 hours where a subject experienced significant impediments in his/her daily activities, and pain medication had to be taken. A visit to a medical facility is not obligatory in this definition.
•-Written informed consent from patient/parent/guardian is given.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 30
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•-Chronic blood transfusion or transfusion in the preceding 3 months
•-Painful crisis in the last 4 weeks (with respect to the moment of inclusion).
•A crisis will be defined as above; a patient defined, painful, sickle cell related episode of at least 24 hours where the subject experienced significant impediments in his/her daily activities, and pain medication had to be taken. A visit to a medical facility is not obligatory in this definition.
•-Pregnancy, breast feeding or the desire to get pregnant in the following 7 months
•-Known active gastric/duodenal ulcers
•-Hydroxycarbamide (HC) treatment with unstable dose in the last 3 months or started on
•HC shorter then 6 months prior to study.
•-Known poor compliance in earlier trials regarding the completion of pain diaries.
•-Insufficient compliance in run-in period.
•Participants that do not show up for their follow-up visit without prior notice, that not bring
•their diary or with less than 80% of the days in the pain diary filled in, will be excluded from participation in this trial and will not be randomized.

发起方

Academic Medical Center