Chronic Hepatitis CPhase 2NCT00601770
Virological Response Study of the HCV Vaccine IC41
A Phase 2 study testing IC41 in people with Chronic Hepatitis C, run by Valneva Austria GmbH at 8 sites in 3 countries.
Trial summary
The objective is to investigate the virological (HCV-RNA) responses following biweekly immunization with IC41. Treatment phase 14 weeks, total study duration including follow-up period 38 weeks. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- IC41
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Feb 2006to Jul 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent obtained prior to study entry
- Patients with chronic hepatitis C; genotype 1
- Treatment naive patients
- Male and Female, 18 to 55 years
- Presence of HLA-A2 marker
- Mentally healthy
- No clinically relevant pathological findings in any of the investigations at screening
- Treatment naive patients with chronic Hepatitis C of genotype 1
Who cannot join
- Positive results in HIV, HBsAg and HAV-Ag (IgM)
- Other causes of chronic hepatitis
- History of autoimmune diseases
- Previous vaccination with any prophylactic or therapeutic Hepatitis C vaccine (in a clinical study)
- Active or passive vaccination 4 weeks before and during the entire study period
- Decompensated liver disease
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- History of severe hypersensitivity reactions and anaphylaxis
- Known allergic reactions to one of the components of the vaccine and Imiquimod cream
- Clinically significant diseases which, in the opinion of the Investigator, might lead to frequent hospitalization/medical attendance
- Malignancies
- Immunosuppressive therapy
- Pregnancy, lactation or breast-feeding
- Unwillingness to practice appropriate contraception
- Participation in another study with an investigational drug within 1 month prior to enrolment and the entire study period
- Patients, who in the opinion of the Investigator, might not be able to comply with the study protocol (e.g.: Drug addiction, alcoholism)
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Romania4 sites
Prof. Dr. Mircea Diculescu
Bucharest, Bucharest, 11461
Dr. Adriana Motoc
Bucharest, Bucharest, 30303
Dr. Adriana Hristea
Bucharest, Bucharest, 72204
Prof. Dr. Carol Stanciu
Iași, Iaşi, 700111
Germany2 sites
Prof. Dr. Ulrich Spengler
Bonn, Bonn, 53105
Prof. Dr. Michael Manns
Hanover, Hannover, 30625
Poland2 sites
Dr. Granzyna Cholewinska-Szymanska
Warzawa, Warzawa, 01201
Prof. Dr. Andrzej Gladszy
Wroclaw, Wroclaw, 51149
About this study
Official title: Open-label, Multicenter Trial With IC41, a Therapeutic HCV Vaccine in Patients With Chronic HCV
The objective is to investigate the virological (HCV-RNA) responses following biweekly immunization with IC41.
Treatment phase 14 weeks, total study duration including follow-up period 38 weeks.
- Conditions
- Chronic Hepatitis C
- Being tested
- IC41
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IC41Biological
injection
| Study group | Role | What they receive |
|---|---|---|
| IC41 | Experimental | 8 injections of 4 x 0.125mL Receives: Biological: IC41 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV-RNA 2 weeks after end of treatment
Measured: 2 weeks
Secondary outcomes (1)
Immunological assays and Safety
Measured: until study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startFeb 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sonja Ernsthofer, Mag, Study director, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601770
- Sponsor's protocol ID
- IC41-202
- Status last verified
- Feb 2014
- First submitted
- 4 Jan 2008
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter Trial With IC41, a Therapeutic HCV Vaccine in Patients With Chronic HCV
- ClinicalTrials.gov ID
- NCT00601770
- Acronym / sponsor ID
- IC41-202
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to investigate the virological (HCV-RNA) responses following biweekly immunization with IC41.
Treatment phase 14 weeks, total study duration including follow-up period 38 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IC41 | Experimental | Biological: IC418 injections of 4 x 0.125mL |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Written informed consent obtained prior to study entry
- Patients with chronic hepatitis C; genotype 1
- Treatment naive patients
- Male and Female, 18 to 55 years
- Presence of HLA-A2 marker
Key exclusion criteria (15 listed)
- Positive results in HIV, HBsAg and HAV-Ag (IgM)
- Other causes of chronic hepatitis
- History of autoimmune diseases
- Previous vaccination with any prophylactic or therapeutic Hepatitis C vaccine (in a clinical study)
- Active or passive vaccination 4 weeks before and during the entire study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IC41injection | Biological | IC41 |
Primary outcome
HCV-RNA 2 weeks after end of treatment
Time frame: 2 weeks
1 secondary outcome
Immunological assays and Safety
Time frame: until study end
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonja Ernsthofer, Mag study director
Valneva Austria GmbH
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IC41 in people with Chronic Hepatitis C, run by Valneva Austria GmbH at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Romania, Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV-RNA 2 weeks after end of treatment (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.