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
ISRCTN | ISRCTN71794661 |
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DOI | https://doi.org/10.1186/ISRCTN71794661 |
Secondary identifying numbers | T2S-918-HCV |
- Submission date
- 09/09/2005
- Registration date
- 30/09/2005
- Last edited
- 15/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Yves Horsmans
Scientific
Scientific
UCL St Luc
Dept Gastroenterology
Avenue Hippocrate 10
Brussels
1200
Belgium
Phone | +32 2 764 2837 |
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horsmans@gaen.ucl.ac.be |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Multi-centre |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | 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. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Chronic hepatitis C (genotype 1). |
Intervention | 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. |
Intervention type | Other |
Primary outcome measure | Liver histology (Ishak score) difference from baseline. |
Secondary outcome measures | 1. Other histology assessments 2. Virological, immunological, and biochemical responses 3. Quality of life 4. Safety evaluation |
Overall study start date | 09/01/2004 |
Completion date | 31/05/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 122 |
Key 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) |
Key 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 |
Date of first enrolment | 09/01/2004 |
Date of final enrolment | 31/05/2007 |
Locations
Countries of recruitment
- Belgium
Study participating centre
UCL St Luc
Brussels
1200
Belgium
1200
Belgium
Sponsor information
Innogenetics NV (Belgium)
Industry
Industry
Technologiepark 6
Zwijnaarde
9052
Belgium
Phone | +32 9 324 2025 |
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info@innogenetics.com | |
Website | http://www.innogenetics.be |
https://ror.org/003dqcp70 |
Funders
Funder type
Industry
Innogenetics NV (Belgium)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |