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
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

UCL St Luc
Dept Gastroenterology
Avenue Hippocrate 10
Brussels
1200
Belgium

Phone +32 2 764 2837
Email horsmans@gaen.ucl.ac.be

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designMulti-centre
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesThe 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) studiedChronic hepatitis C (genotype 1).
InterventionThis 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 typeOther
Primary outcome measureLiver histology (Ishak score) difference from baseline.
Secondary outcome measures1. Other histology assessments
2. Virological, immunological, and biochemical responses
3. Quality of life
4. Safety evaluation
Overall study start date09/01/2004
Completion date31/05/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants122
Key inclusion criteria1. 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 criteria1. 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 enrolment09/01/2004
Date of final enrolment31/05/2007

Locations

Countries of recruitment

  • Belgium

Study participating centre

UCL St Luc
Brussels
1200
Belgium

Sponsor information

Innogenetics NV (Belgium)
Industry

Technologiepark 6
Zwijnaarde
9052
Belgium

Phone +32 9 324 2025
Email info@innogenetics.com
Website http://www.innogenetics.be
ROR logo "ROR" https://ror.org/003dqcp70

Funders

Funder type

Industry

Innogenetics NV (Belgium)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan