HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a Methadone Maintenance Treated (MMT) Opioid Addicted Group.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- - Percent of patients with sustained virological response, defined as undetectable HCV RNA 24 weeks after end of treatment
研究概览
简要总结
- To evaluate if weekly psychological follow-up make opioid dependent patients in MMT able to accomplish 14 weeks treatment with Peginterferon alfa-2a (PEG-INF) and ribavirin to the same extent than non-opioid dependents.
- To determine the efficacy of this anti-HCV treatment
详细描述
Chronic infection with the hepatitis C virus (HCV) is a health problem worldwide. In Norway, there are about 3000 patients participating in Methadone Maintenance Treatment(MMT) programs. A prevalence study at the MMT treatment unit in Kristiansand, showed that more than 90 % of 177 patients have been infected with hepatitis C.
A major problem with anti-HCV treatment for this group is the lack of compliance and retention in treatment. Further, due to the high incidence of psychological disorders in opioid dependent patients, this may also complicate anti-HCV treatment. Drug addicted in MMT treatments programs may find themselves excluded from Hepatitis C treatment.
Due to better treatment efficacy with the new PEG-INF's and encouraging reports from 14 weeks studies, it may be easier to motivate opioid dependents to fulfill treatment. Weekly psychological follow-up of these patients will further increase the possibility of opioid dependents in MMT to be able to complete anti-HCV treatment.
The aim of this study is to focus on this patients situation, and strengthen their possibility to have a real opportunity to get treatment. We therefore wish to make a pilot study to investigate the feasibility, efficacy and psycological side-effects of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serologic evidence of hepatitis C infection, genotype 2 and 3
- •Normal or elevated serum ALT activity
- •In MMT-programme and with at least 6 months with satisfactory drug abuse control. That means no iv injections and no or minimal use of drugs.
- •Male and female patients
排除标准
- •Women with ongoing pregnancy or breast feeding
- •Untreated serious psychiatric disorders, particularly depression.
- •Serious drug abuse or alcohol abuse last 6 months
- •Intravenous drug abuse last 6 months
- •Hepatitis A, B or HIV infection
- •HCV genotype 1, 4, 5 and 6
- •Leucocytes < 3000 cells/mm3 at screening (neutrophil count <1500 cells/mm3)
- •Platelet count < 80 000 cells/mm3 at screening
- •Hb <11 g/dL in women or <12 g/dL in men at screening
- •Documented or presumed coronary artery disease or cerebrovascular disease
- •Thyroid dysfunction not adequately controlled
- •Malignant disease
结局指标
主要结局
- Percent of patients with sustained virological response, defined as undetectable HCV RNA 24 weeks after end of treatment
时间窗: 24 weeks after end of treatment
次要结局
- Retention in treatment, compliance, psychological distress, measures of quality of life, perceived drug use control and urine toxicology(2, 4, 8, 14 and 24 weeks after study start)