Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine in Patients With Primary Immune Thrombocytopenia Resistant to Steroid Treatment or in Relapse: An Exploratory Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change from Baseline (before intervention) in the Mean Serum Platelet Count at 1, 3, 6 and 12 Months
研究概览
简要总结
The purpose of this study is to assess the ability of Atorvastatin and N-acetyl cysteine to elevate the blood (serum) platelet count in patients with Immune Thrombocytopenia as a mean of a new treatment.
详细描述
Evaluate the efficacy in the elevation of platelet count of the combination of atorvastatin and N-acetyl cysteine in patients with immune thrombocytopenia resistant to steroid therapy or with relapse after treatment, a prospective, proof of concept clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that give their informed consent before the procedures of study
- •Thrombocytopenia before intervention (<100 x10^9 /L)
- •Patients of either biological sex older than 15 years old
- •Patients with previous diagnosis of primary immune thrombocytopenia that not reach complete remission after treatment (steroid based) or that have a relapse
- •If the patient is taking steroid based treatment, the dose need to be stable before intervention.
排除标准
- •Patients with secondary immune thrombocytopenia
- •Pregnant patients
- •Patients with hypersensitivity to study treatments
- •Patients that are taking anticoagulant medication or any drug that have an effect on platelet count
- •Hepatic alteration consisting in serum levels of Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3 times above superior laboratory reference limit.
- •Elevation of serum levels of Creatinine or bilirubins above 1.5 mg/dl
- •Any cancer diagnosis
- •Coronary heart disease, congestive heart failure, uncontrolled hypertension or arrhythmias.
- •Previous autoimmune disease diagnosis including: systemic lupus erythematosus, rheumatoid arthritis or systemic sclerosis.
研究组 & 干预措施
Atorvastatin + N-acetylcysteine
Patients included in the study received an oral treatment of Atorvastatin 40 mg daily and N-acetylcysteine 400 mg every 8 hours, for at least 1 month (up to 12 months)
干预措施: Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet (Drug)
结局指标
主要结局
Change from Baseline (before intervention) in the Mean Serum Platelet Count at 1, 3, 6 and 12 Months
时间窗: Baseline and 1, 3, 6, and 12 months after intervention
Blood samples of all participants will be taken previous to the intervention of study and in the 1, 3, 6, adn 12 month, this with the objective of evaluate changes in platelet count after intervention expecting to elevate the platelet count.
次要结局
未报告次要终点
研究者
Enrique Cervantes-Perez
Attending Internal Medicine Physician and Professor to the Department of Internal Medicine, Hospital Civil de Guadalajara "Fray Antonio Alcalde".
Hospital Civil de Guadalajara