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 design	Randomised controlled trial
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
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

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"	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 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