Randomized, controlled Study of Methadone and Buprenrphine in Hepatitis C patients in need of treatment

AESCA Pharma GesmbH0 个研究点目标入组 128 人开始时间: 2005年3月31日最近更新: 2013年4月29日

试验速览

暂无简介。

•male and female patients with a history of iv drug abuse, who are willing to undergo methadone or buprenorphine substitution
•patients with newly diagnosed chronic hepatitis C
•age 18 - 65
•HCV-RNA positive in serum as measured by PCR within the last 4 weeks
•genotype 2 or 3
•elevated ALT levels
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•·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
•·confirmed co-infection with HIV or 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)

发起方

AESCA Pharma GesmbH