Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Platelet count
研究概览
简要总结
Hydroxychloroquine has been reported to have a clinically significant effect on the platelet count in systemic lupus thrombocytopenia. Its action may be due to its immune modulator effect. Immune thrombocytopenia (ITP) is known as an immune-mediated acquired disease characterized by transient or persistent decrease of the platelet count. However, refractory ITP is lacking of effective treatments and the efficacy of decitabine in ITP remains poorly understood. Data from this study may provide some idea of Hydroxychloroquine in the treatment of ITP in comparison to other lines of treatment as detected by the standardized definitions.
详细描述
This study will include patients with chronic ITP attending the out patients clinic of Clinical Hematology Unit of Internal Medicine Department of Assiut university Hospital to evaluate the safety and efficacy of hydroxychloroquine in comparison to other lines of treatment as detected by the standardized definitions . Detect the predictors for chronic ITP especially anti-nuclear antibodies (ANA) role and the effect of the proposed drugs on the level of anti-platelet antibodies. Evaluation of the health-related quality of life after treatments to answer this question; Is the most effective drug is linked to the best quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •We will recruit patients with primary chronic ITP patients with ITP lasting for more than 12 months which is proved to be refractory to the standard first line treatment or need to treatment(s) (including, but not limited to, low dose of corticosteroids) to minimize the risk of clinically significant bleeding.
- •Subject or their guardian has signed and dated a written informed consent.
- •Subject experienced no toxicity or known contraindication to any line of treatments.
排除标准
- •pregnancy.
- •liver and kidney function impairment.
- •hepatitis c virus(HCV), human immunodeficiency virus (HIV), hepatitis B virus infection.
- •patients with systemic lupus erythematosus and/or antiphospholipid syndrome
- •lymphoproliferative disorders.
- •an active malignancy
- •an arterial or venous thrombosis
- •Grade III-IV cardiovascular disease .
- •Recent history of alcohol/drug abuse.
- •Subjects recently treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for > 3 consecutive days within 2 weeks of the study start and until the end of the study.
研究组 & 干预措施
hydroxychloroquine group
hydroxychloroquine tablets 200mg ,two times/day for at least 6 month
干预措施: Hydroxychloroquine (Drug)
vincristine group
vincristine ampoule , 1mg/ week, I.v drep over 2 hours for 4 weeks
干预措施: vincristine (Drug)
azathioprine group
azathioprine tablet 50mg, dose 100-150 mg daily for 6 month
干预措施: azathioprine (Drug)
结局指标
主要结局
Platelet count
时间窗: Follow up untill response or death from any cause up to six months
to detect response as the standard definition
side effects
时间窗: Up to six months
any complication for any line of treatments line
次要结局
- anti- nuclear antibodies role(before enrollment)
- Anti-platelets antibodies role(after6 months)
- Health quality life(after 6 months of treatment)
研究者
Ghada E. M. Abdallah
Principal investegator
Assiut University