Contact information
Type
Scientific
Primary contact
Prof Yves Horsmans
ORCID ID
Contact details
UCL St Luc
Dept Gastroenterology
Avenue Hippocrate 10
Brussels
1200
Belgium
+32 2 764 2837
horsmans@gaen.ucl.ac.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
T2S-918-HCV
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
09/01/2004
Overall trial end date
31/05/2007
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
122
Participant 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
Recruitment start date
09/01/2004
Recruitment end date
31/05/2007
Locations
Countries of recruitment
Belgium
Trial participating centre
UCL St Luc
Brussels
1200
Belgium
Sponsor information
Organisation
Innogenetics NV (Belgium)
Sponsor details
Technologiepark 6
Zwijnaarde
9052
Belgium
+32 9 324 2025
info@innogenetics.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Innogenetics NV (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary