Condition category
Infections and Infestations
Date applied
09/09/2005
Date assigned
30/09/2005
Last edited
15/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.innogenetics.be

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

Publication citations

Additional files

Editorial Notes