Treatment of Acute Hepatitis C Virus Infection in Injection Drug Users With Pegylated Interferon for 24 Weeks
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Sustained viral response rate in treatment group versus control (measured at Week 24)
研究概览
简要总结
Injection drug use accounts for transmission of a high proportion of Hepatitis C Virus (HCV) infections. The purpose of this trial is to investigate the effectiveness of pegylated interferon in treating injection drug users (IDUs) with acute HCV.
详细描述
IDUs are at high risk for developing HCV. Pegylated interferon is a man-made form of interferon, a chemical naturally produced by the body that works to fight viruses. Interferon helps to stop HCV from replicating, and helps the immune system to kill HCV. The purpose of this trial is to determine the effectiveness of pegylated interferon in IDUs with HCV.
This trial will last 24 weeks. Participants will be randomly assigned to one of two groups. Group 1 will receive pegylated interferon while group 2 will receive an active control. Injection with either pegylated interferon or control will occur weekly. During each injection visit, participants will be asked about adverse events, including common side effects to interferon such as injection site reactions, headache, myalgias, arthralgias, insomnia, and hair loss. At Weeks 2, 4, and then every 4 weeks thereafter, participants will complete depression self-reports. Laboratory assessments will occur at Week 2, and then on a monthly basis for the remainder of the study. Follow-up assessments will occur every 4 weeks after Week 24.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented HCV antibody seroconversion within the 12 months prior to study entry
- •Serum positive for HCV
- •Meets hematologic, biochemical, and serologic criteria at entry visit
- •Thyroid stimulating hormone within normal limits
- •Hepatitis B surface antigen negative
- •Reads at an eighth grade reading level
- •Willing to use adequate contraception for the duration of the study
- •Plans to remain in the study area for 12 months
排除标准
- •Positive test for Hepatitis A antibodies, Hepatitis B antibodies, or HIV antibodies
- •Suspected hypersensitivity to pegylated interferon
- •Liver disease
- •Hemoglobinopathies
- •Immune mediated disease
- •Significant cardiac or pulmonary disease
- •Uncontrolled seizure disorder
- •Renal insufficiency with serum creatinine levels greater than 11.5 mb/ml or less than 60 mb/ml
- •History of thyroid disease
- •Active gout
- •Any medical condition requiring or likely to require steroids during the course of study
- •Untreated severe psychiatric disorder, as determined by study psychiatrist
- •Any condition, which in the opinion of the investigator, would preclude successful completion of the study
- •Pregnant or breastfeeding
研究组 & 干预措施
PegInterferon
Arm 1: 24 weeks of weekly injections of peginterferon Arm 2: control (no treatment)
干预措施: Pegylated Interferon (Drug)
结局指标
主要结局
Sustained viral response rate in treatment group versus control (measured at Week 24)
时间窗: 24 weeks
次要结局
- Adherence rate in the treatment group (measured at Week 24)(24 weeks)