A Randomized Trial Comparing a Short Course Versus Standard Treatment in Patients With Chronic Hepatitis C Virus Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Sustained Virological response
研究概览
简要总结
To determine if a shorter course of interferon and ribavirin therapy will be sufficient in carefully selected patients with chronic hepatitis C virus genotype 3 infection, as compared to the standard length of treatment of 6 months.
详细描述
- INTRODUCTION
1.1 Hepatitis C Hepatitis C Virus (HCV) is a major cause of chronic hepatitis and hepatic fibrosis1. Acute infection advances to chronicity in up to 80% of patients, which can further progress to cirrhosis and hepatocellular carcinoma in a significant number1.
Hepatitis C is a global problem, prevalent in industrialized as well as in the developing world2. It is a major cause of chronic liver disease (CLD) in Pakistan and has surpassed hepatitis B as the single most important cause for cirrhosis and hepatocellular carcinoma (HCC) in Pakistan 3.
1.2 Study Medications A combination of interferon and ribavirin therapy has been the standard of care world-wide for the past few years1, 2. Standard treatment duration is for 24 weeks for genotype non 1, and 48 weeks for genotype 12.
1.2.1 Interferon Alfa 2a Interferon Alfa was the first drug shown to have bioactivity against HCV. Combining ribavirin with interferon Alfa was found to be more effective than interferon Alfa mono-therapy in previously untreated patients as well in patients who relapsed after one or more courses of interferon Alfa therapy2.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and non-pregnant females (more than 18 and less than equal to 50 years of age).
- •Treatment naïve patients.
- •Serological evidence of hepatitis C infection by an anti-HCV antibody test
- •HCV PCR positive
- •Genotype 3
- •Absence of cirrhosis on liver biopsy.
- •Absence of alcohol or drug abuse.
排除标准
- •Patients who do not consent to be included in the study.
- •Pregnant or breast feeding females.
- •Patients with a hemoglobin of <10g/dl, ANC <1500c/mm, and a platelet count <90000c/mm.
- •Genotype non 3
- •HCV PCR positive at the end of 4 weeks of treatment.
- •Presence of cirrhosis on liver biopsy.
- •Decompensated liver disease.
- •History or other evidence of a medical condition associated with chronic liver disease other than CHC (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)
- •History of having received IFN, PEG-IFN, RBV therapy previously.
- •History of systemic antiviral therapy or investigational drug 3 months prior to the first dose of study treatment.
- •Patients expected to need systemic antiviral therapy at any time during their participation in the study.
- •Exceptions from the last two exclusion criteria are patients who have had a limited (less than 7 day) course of acyclovir or valacyclovir for herpetic lesions more than 1 month prior to the first administration of trial treatment.
研究组 & 干预措施
1
16 weeks Interferon Tiw with Ribavirin
干预措施: 16 weeks Interferon Tiw with Ribavirin (Drug)
2
24 weeks Interferon Tiw with Ribavirin
干预措施: 24 weeks Interferon (Drug)
结局指标
主要结局
Sustained Virological response
时间窗: six months after stopping treatment
次要结局
- Safety of short course of Interferon & Ribavirin(Four or Six months)