Therapeutic vaccination in patients with chronic hepatitis C genotype 1 using four courses of 8 + 6 + 6 + 6 intramuscular injections of 50 µg E1y at 3 week intervals: a multicenter, 3:1 randomized, double-blind, placebo-controlled, parallel-group study over 157 weeks in 122 patients

Innogenetics NV (Belgium)0 个研究点目标入组 122 人开始时间: 2005年9月30日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Male and female patients 18 to 70 years old with compensated chronic hepatitis C genotype 1 infection
•2. Female patients of childbearing potential should use an efficient method of contraception
•3. Patients should either have failed to respond to interferon (IFN)-based therapy or have contraindications to IFN-based therapy or have decided not to start IFN-based treatment (after having been well informed)

•1. Prior (within last 3 months) or planned concomitant use of other hepatitis C treatment, immunosuppressive, or hepatotoxic treatment
•2. Malnutrition or severe medical conditions or medical conditions associated with immunosuppression, including end stage renal failure or cancer
•3. Severe symptomatic cryoglobulinemia, active autoimmune hepatitis, uncontrolled diabetes, or uncontrolled thyroid disease
•4. HIV infection, active hepatitis B infection
•5. Alcohol or intravenous drug abuse during the last year
•6. Ongoing medical condition associated with chronic liver disease other than hepatitis C

发起方

Innogenetics NV (Belgium)