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 sites122 target enrollmentSeptember 30, 2005

Overview

No summary available.

Registry

who.int

Start Date

September 30, 2005

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

Innogenetics NV (Belgium)

•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