NCT00279565终止4 期
Randomized, Controlled Study of Buprenorphine and Methadone in Hepatitis C Patients in Need of Treatment
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 128
研究概览
简要总结
This randomized, single-center, controlled study is designed to evaluate the safety, tolerability, and efficacy of treatment with Peg-Intron with Rebetol in methadone or buprenorphine maintenance patients with hepatitis C.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with a history of intravenous drug abuse, who are willing to undergo methadone or buprenorphine substitution.
- •Patients with newly diagnosed chronic hepatitis C.
- •Hepatitis C virus (HCV)-ribonucleic acid (RNA) positive in serum as measured by polymerase chain reaction (PCR) within the last 4 weeks.
- •Genotype 2 or
- •Elevated alanine aminotransferase (ALT) levels.
- •In women of child-bearing age, pregnancy must be excluded prior to entry into the study, and the use of a safe contraceptive device (intrauterine device, oral contraceptive, diaphragm + spermicide, condom + spermicide, tubal ligation) must be documented.
- •Lab parameters:
- •Hemoglobin: >=12 g/dL (women) or >=13 g/dL (men)
- •Leukocytes >=3,000/µL
- •Thrombocytes >=100,000/µL
- •Prothrombin time (PT)/partial thromboplastin time (PTT)/coagulation within the normal range
- •Albumin: not more than 10% deviation from lower normal value
- •Thyroid-stimulating hormone (TSH) normal
- •Creatinine normal
- •Uric acid normal
- •Antinuclear antibodies <=1:160
- •Signed informed consent.
排除标准
- •Refusal by women of child-bearing age or by sexually active patients to use a safe contraceptive.
- •Breast-feeding women.
- •Cirrhosis stage B and C according to Child-Pugh.
- •Signs of decompensated liver disease (ascites, bleeding varices and spontaneous encephalopathy).
- •Confirmed co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV).
- •Existing psychiatric comorbidity.
- •Alcohol abuse.
- •Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma).
- •Existing psoriasis or other dermatological disorder (relative exclusion criterion: due to great differences with regard to the severity of the disorder and the individual therapy compatibility, the therapy decision is at the discretion of the physician).
- •Treatment with a study drug within the last 30 days.
- •Any uncontrolled underlying medical conditions (e.g. diabetes).
- •Clinically significant electrocardiogram (ECG) abnormalities and / or significant cardiovascular dysfunction within the last 6 months (angina, heart failure, recent myocardial infarction, severe hypertension or significant arrhythmia) is an exclusion criterion. In case of other suspected heart disease, a cardiologic examination is required prior to inclusion of the patient.
- •Any liver disorder of other genesis than the study indication (with regard to elevated iron levels, only patients with manifest hemochromatosis are excluded).
- •Autoimmune disorder (except LKM-positive patients: these patients may be included in the study).
- •Misuse of buprenorphine or methadone.
研究者
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