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

Completed

• Conditions: Chronic hepatitis C (genotype 1).; Infections and Infestations; Hepatitis

• Registration Number: ISRCTN71794661
• Lead Sponsor: Innogenetics NV (Belgium)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified