A Double Blind Placebo Controlled Randomized Trial of Ribavirin in Patients With Acute on Chronic Liver Failure Due to Hepatitis E Virus
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Improvement in survival
研究概览
简要总结
The term Acute on chronic liver failure (ACLF) describes a clinical entity characterized by an acute and rapid deterioration of liver function in a patient with previously well-compensated liver disease owing to the effects of a precipitating event. In this condition two insults act simultaneously, one being the preexisting liver injury (chronic liver disease) and the other acute injury which is responsible for the acute decompensation. HEV being a major factor responsible for this clinical entity and has a very high mortality rate. Ribavirin being a safe drug and has been shown to inhibit the replication of HEV, can be an important drug in the treatment of these patients. Therefore the present study is designed to study the impact of Ribavirin in reducing the mortality due to HEV related ACLF.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All ACLF due to HEV
- •Consent to participate in trial and collection of blood.
排除标准
- •Pregnant and nursing mothers.
- •Severe anemia
- •Other etiologies of ACLF (eg. Alcohol, drugs, reactivation of hepatitis B and hepatitis C, variceal bleeding, surgical intervention and sepsis)
- •Hepatocellular carcinoma (HCC)
- •Hepatorenal syndrome (HRS) at admission
- •Presence of life threatening cardiovascular, respiratory and neurological disease
- •Acquired Immunodeficiency Syndrome
- •Patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)
- •Refusal to provide consent to participate in the study
研究组 & 干预措施
Ribavirin
1000 mg (5 capsules)
干预措施: Ribavirin (Drug)
Placebo
5 capsules of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in survival
时间窗: 4 weeks and 12 moths
次要结局
- Child Score(4 weeks and 12 months)
- Viremia(4 weeks, 3 months)
- Variceal bleeding(4 weeks and 12 months)
研究者
Subrat Kumar Acharya
Professor
All India Institute of Medical Sciences, New Delhi