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ISRCTN
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ISRCTN71794661
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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T2S-918-HCV
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Study hypothesis
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The following hypothesis will be tested: Null hypothesis: mean difference from baseline in liver histology (Ishak score) for the E1y treated patients = mean difference from baseline in liver histology (Ishak score) for the patients who received placebo.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Belgium
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Disease/condition/study domain
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Chronic hepatitis C (genotype 1).
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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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
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Anticipated start date
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09/01/2004
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Anticipated end date
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31/05/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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122
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Interventions
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This is a prospective, 3:1 randomized, multicenter, double-blind, placebo-controlled, parallel-group study of four courses of 8 + 6 + 6 + 6 IM injections of 50 µg E1y over 157 weeks in 122 genotype 1 chronic hepatitis C patients.
E1y or placebo treatment was allocated 3:1 using a central randomization procedure. Approximately 90 patients will receive a first course of eight injections of E1y at 3-week intervals, followed by three courses of six injections of E1y at 3-week intervals. Approximately 30 patients will receive a first course of eight injections of placebo at 3-week intervals, followed by three courses of six injections of placebo at 3-week intervals. Four weeks after the last study drug injection an end-of-study liver biopsy will be performed.
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Primary outcome measure(s)
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Liver histology (Ishak score) difference from baseline.
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Secondary outcome measure(s)
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1. Other histology assessments
2. Virological, immunological, and biochemical responses
3. Quality of life
4. Safety evaluation
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Sources of funding
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Innogenetics NV (Belgium)
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Trial website
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Publications
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Contact name
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Prof
Yves
Horsmans
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Address
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UCL St Luc
Dept Gastroenterology
Avenue Hippocrate 10
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City/town
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Brussels
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Zip/Postcode
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1200
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Country
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Belgium
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Tel
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+32 2 764 2837
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Fax
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+32 2 764 8927
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Email
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horsmans@gaen.ucl.ac.be
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Sponsor
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Innogenetics NV (Belgium)
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Address
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Technologiepark 6
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City/town
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Zwijnaarde
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Zip/Postcode
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9052
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Country
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Belgium
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Tel
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+32 9 324 2025
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Fax
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+32 9 324 2028
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Email
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info@innogenetics.com
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Sponsor website:
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http://www.innogenetics.be
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Date applied
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09/09/2005
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Last edited
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15/09/2009
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Date ISRCTN assigned
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30/09/2005
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