The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Sustained Viral Response,
研究概览
简要总结
The purpose of this study is to investigate if nitazoxanide used in combination with interferon alfa and ribavirin is effective in treating Hepatitis c infected type 2 Diabetic patients by improving their sustained viral response by more than 80%.Considering that the study is being conducted in a third world country like Pakistan, the standard treatment of hepatitis C is not cost effective. The aim is to introduce a new treatment comparable in efficacy to peginterferon and also cost effective.
详细描述
After taking proper informed consent from patients, patients who fulfill the research criteria are randomized into 2 groups (control/study). Patients in both groups will be treated with conventional interferon alfa and Ribavirin.Those in study group will be given tab nitazoxanide 500mg twice daily in addition to conventional treatment. The patients will be followed up at regular intervals: 0,4,12,24,48 week.At each visit Hepatitis C Virus(PCR)RNA, Liver function tests, complete blood count will be done.
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
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatitis C genotype 3a
- •Hepatitis C Virus(PCR)RNA Detected
- •Alanine transaminase >60
- •Diabetic HbA1c<8
排除标准
- •Previously treated Hepatitis C patients
- •Pregnant females
- •Decompensated liver disease,Child class B OR above
- •Thyroid disease,Thyroid stimulating hormone>10,0.05
- •Absolute neutrophil count<1500,Platelets<80,000,Hb<10g Female,<11g Male
- •Severe cardiac disease,New York Heart Association2
- •Moderate to severe depression assessed by Beck Depression Inventory scale
研究组 & 干预措施
study group
Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months
干预措施: nitazoxanide (Drug)
study group
Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months
干预措施: conventional interferon alfa (Drug)
study group
Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months
干预措施: Ribavirin (Drug)
control group
Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months
干预措施: conventional interferon alfa (Drug)
control group
Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months
干预措施: Ribavirin (Drug)
结局指标
主要结局
Sustained Viral Response,
时间窗: 48 WEEK
Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.
次要结局
- Normalization of Alanine Transferase Test(48week)
研究者
Prof. Faisal Masud
Principal SIMS
Services Institute of Medical Sciences, Pakistan