ACTRN12608000400369招募中4 期
A single-arm, open-label, pilot study evaluating the efficacy and safety of directly observed peginterferon alfa-2a with ribavirin in conjunction with a peer counsellor in patients actively using injecting drugs who have chronic hepatitis C and attend a drug and alcohol centre.
Dr Joe Sasadeusz0 个研究点目标入组 50 人开始时间: 2008年8月8日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Informed consent
- •Age = 18 years
- •Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test and positive HCV PCR (Polymerase Chain Reaction) for > 6 months
- •Detectable serum HCV-RNA (ribonucleic acid) at screening
- •Compensated liver disease (Child-Pugh Grade A clinical classification)
- •Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
- •All fertile males and females and their partners must be using effective contraception during treatment and during the 6 months after treatment end
- •Have had an episode of injecting drug use within 4 weeks of screening
- •Drinking 2 standard drinks or less of alcohol per day ( binge drinking will be allowed as long as it does not exceed 6 standard drinks for males and 4 standard drinks for females less than every 2 weeks)
排除标准
- •Frequency of injecting drug use of daily or greater
- •Females who are pregnant, breastfeeding or planning a pregnancy
- •Inability or unwillingness to provide informed consent or abide by the requirements of the study protocol
- •Patients unwilling to use an acceptable method of birth control (defined as surgical sterility, intrauterine device, oral contraception, diaphragm or condom in association with a spermicide)
- •Patients previously treated with interferon or ribavirin
- •Evidence of excessive substance abuse as judged by the investigator
- •Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) <=6 months prior to the first dose of study drug
- •Any investigational drug <=4 weeks or 5 half lives, whichever is longer, prior to the first dose of study drug
- •Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab
- •History or other evidence of a medical condition associated with chronic liver disease other than HCV (eg. hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease)
- •History or other evidence of bleeding from oesophageal varices or other conditions consistent with decompensated liver disease as evidenced by Child’s Pugh score B or C
- •Neutrophil count <1500 cells/mm3 or platelet count <75,000 cells/mm3 at screening
- •Serum creatinine level >1.5 times the upper limit of normal at screening
- •History of severe psychiatric disease (defined as schizophrenia, active bipolar disorder, severe anorexia, serious or multiple episodes of self harm, currently high or moderate suicide risk, current major depressive episode or current psychosis)
- •History of a severe seizure disorder or current anticonvulsant use
- •History of immunologically-mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- •History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
- •Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
- •Hgb <12 g/dL in women or <13 g/dL in men at screening
- •Any patient with an increased baseline risk for anaemia (e.g. thalassemia, spherocytosis, history of gastrointestinal (GI) bleeding, etc) or for whom anaemia would be medically problematic
- •Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in haemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
- •Other significant comorbidity or contraindication to therapy of study participation as determined by investigator
研究者
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