Efficacy of Eltrombopag & Prednisolone Versus Prednisolone Monotherapy in Newly Diagnosed Immune Thrombocytopenia- A Randomized Control Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Spontaneous bleeding
研究概览
简要总结
This will be a double-blind, placebo-control, randomized clinical trial conducted in the Department of Hematology, DMCH for one year. This study will help to establish the role of eltrombopag as a first-line therapy in newly diagnosed ITP. Newly diagnosed ITP patients will be selected after meeting inclusion and exclusion criteria, they will be thoroughly informed about the study, used drugs, randomization, risks, benefits, and follow-up. If they agree to participate, their consent will be taken and they will be enrolled in the study. A detailed history and clinical exam will be done. Primary investigation will be - CBC PBF, RBS, ANA, TSH, Anti H. pyloriIgG, Anti-HCV, APTT, and BMS (if indicated). The main outcome variable will be platelet count and number of spontaneous bleeding. Total sample size would be 100 (50 in each group). Enrolled patients would be divided into two groups (1:1) by block randomization. One group will get Eltrombopag& Prednisolone and other group will get Eltrombopag& Placebo. Researchers or any one related to the study in DMCH, patients & their attendants, no one will know which patient will get placebo or eltrombopag. Only a respectable third party will know the information. A patient would be followed up on 1st, 2nd and 4th week of starting therapy. Patients would be evaluated in every follow up by history, physical examination and investigation. History of any spontaneous bleeding event, any discomfort or new symptoms science last follow up will be noted. General examination will be performed in every follow-up. CBC, RBS, ALT, AST, creatinine will be done in every follow-up. Data will be collected on a pre-designed case record form and will be collected through face-to-face interviews, physical examination, and laboratory reports. After data collection data will be edited, cleaned, and prepared for analysis at the end of the study. The statistical analysis will be conducted using SPSS version 25 statistical software. The results of the study will be published in national and international journals.
详细描述
Study procedure After meeting inclusion and exclusion criteria patients will be thoroughly informed about the study, used drugs, randomization, risk and benefits, follow up. If they agree to participate in the study, their consent for this study will be taken and they will be enrolled in the study.
Detail history and clinical exam will be done. Key points are- History of spontaneous bleeding in last month, History of vaccination, History of recent viral infection, fever, Presence of organomegaly.
Primary investigation will be- CBC PBF, RBS, ANA, TSH, Anti H. pyloriIgG, Anti-HCV, APTT, BMS (if indicated)
NB:
- If APTT is more than 10 sec of control, patient would be evaluated for Anti-Phospholipid Syndrome by anti-cardiolipin Antibody and Anti-beta2 glycoprotein1 Antibody
- If Hemoglobin in less than 11.5gm/dL patient would be evaluated for Anemia by Iron Profile or Coomb's Test based on CBC parameter and PBF findings] Randomization: Enrolled patients would be divided into two groups (1:1) by block randomization. Block Randomization would be done by computer generated pattern. Actual randomization plan will be provided by Renata limited team who know about eltrombopag and placebo. Randomization allocation delivered only to the enrolling site study staff. A voluntary nurse will be in charge of enrolling the patients according to randomization plan.
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
- Double (Participant, Investigator)
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
- •Patients with newly diagnosed ITP
- •Platelet Count ≤ 30x109/L
- •Age between 18 to 70 years.
排除标准
- •Persistent or chronic ITP
- •Pregnant women
- •Secondary ITP- ITP due to SLE, Anti-phospholipid syndrome, Evans syndrome, HCV or H Pylori associated ITP.
- •History of vaccination, recent viral infection, fever
- •Evan's Syndrome
- •Known case of chronic renal failure or liver diseases
- •Grade 3 or 4 bleeding at presentation.
研究组 & 干预措施
Eltrombopag Arm
Eltrombopag + Prednsolone
干预措施: Eltrombopag 25 MG (Drug)
Eltrombopag Arm
Eltrombopag + Prednsolone
干预措施: Prednisolone (Drug)
Prednisolone alone arm
Placebo + Prednisolone
干预措施: Prednisolone (Drug)
结局指标
主要结局
Spontaneous bleeding
时间窗: 28 days (Spontaneous bleeding episodes will be noted by face to face interview at the end of 1st, 2nd and 4th week)
Compare number of Spontaneous bleeding in two groups
Changes in Platelet count
时间窗: 28 days (platelet count will be measured at the end of 1st, 2nd and 4th week)
Compare change in platelet count in two groups
次要结局
- Changes in Total WBC count(28days (WBC count will be measured at the end of 1st, 2nd and 4th week))
- Change in S.Createnine(28 days (S.Createnine will be measured at the end of 1st, 2nd and 4th week))
- Change in ALT(28 days ( ALT will be measured at the end of 1st, 2nd and 4th week))
- Changes in hemoglobin(28 days (hemoglobin will be measured at the end of 1st, 2nd and 4th week))
- Change in AST(28 days ( AST will be measured at the end of 1st, 2nd and 4th week))
- Change in RBS(28 days (RBS will be measured at the end of 1st, 2nd and 4th week))