Chronic Hepatitis CPhase 2NCT00602784
Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine
A Phase 2 study testing IC41 in people with Chronic Hepatitis C, run by Valneva Austria GmbH.
Trial summary
The objectives are 1. to determine the immunological profile (CD4+, CD8+ cells, DTH) induced by immunization with HCV antigen peptide vaccine with polyarginine. 2. to document virological (HCV-RNA) and biochemical (ALT) responses following immunization with HCV antigen peptide vaccine with polyarginine. 3. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- IC41
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Sep 2004
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic hepatitis C
- Non-response to or relapse from primary standard HCV therapy
- HLA A2 positive
- HCV-RNA positive
- HCV antibodies positive
- Liver biopsy within 30 months prior to inclusion
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- Hematology and biochemistry laboratory results within the limits normally expected for the patient population (liver values maximal 5 times the upper limit of normal)
- Male and female
- From 18 to 65 years
- Written informed consent obtained prior to study entry
Who cannot join
- Any degree of liver cirrhosis or fibrosis of Ishak score ≥ 4 (for grading table, see APPENDIX 2: The Ishak Modified Hepatic Activity Index (HAI))
- Any liver disease other than hepatitis C
- History of autoimmune disease
- Immunodeficiency including post-organ-transplantation
- HIV infection
- Immunosuppressive therapy
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- Any acute infections within 4 weeks prior to inclusion
- History of severe hypersensitivity reactions, anaphylaxis or atopy
- Diabetes mellitus, severe cardiopulmonary disorders, history of malignancy in the past 5 years
- Active or passive vaccination within 2 months prior to enrolment, and concomitant vaccination throughout the study period
- Pregnancy or lactation
- Unreliable contraception
- Alcohol consumption
- Drug abuse or addiction within 12 months prior to inclusion
- Participation in a methadone program
- Participation in another study within 1 month prior to enrolment
About this study
Official title: Double Blind, Randomized, Multicenter, Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine Together With Polyarginine, HCV Peptide Vaccine Alone, or Polyarginine Alone, in Patients With Chronic HCV Having Not Responded to or Relapsed From Primary Standard HCV Therapy
The objectives are
- to determine the immunological profile (CD4+, CD8+ cells, DTH) induced by immunization with HCV antigen peptide vaccine with polyarginine.
- to document virological (HCV-RNA) and biochemical (ALT) responses following immunization with HCV antigen peptide vaccine with polyarginine.
- to assess the safety of immunization with HCV antigen peptide vaccine with polyarginine.
Read the detailed description
This is a double blind, randomized, parallel group, controlled, multicenter phase II study.
60 patients will be enrolled and assigned to one of the 5 dose or control groups. Each study group will include 8 patients.
Each patient will receive a total of 6 injections according to the dose of the assigned study group. The injections will be administered subcutaneously in the upper arm once every four weeks for 5 months, i.e. at days 1, 29, 57, 85, 113 and 141.
The volume of each injection will be 0.5 ml in all groups.
- 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
| Study group | Role | What they receive |
|---|---|---|
| IC41-B-01/02 | Experimental | peptide dose 0.00 mg, polyarginine dose 2.00 mg Receives: Biological: IC41 |
| IC41-C-01/02 | Experimental | peptide dose: 5.00 mg, polyarginine dose: 0.00 mg Receives: Biological: IC41 |
| IC41-G-01/02 | Experimental | peptide dose: 2.50 mg, polyarginine dose: 1.25 mg Receives: Biological: IC41 |
| IC41-H-01/02 | Experimental | peptide dose: 2.50 mg, polyarginine dose: 2.00 mg Receives: Biological: IC41 |
| IC41-K-01/02 | Experimental | peptide dose: 5.00 mg, polyarginine dose: 2.00 mg Receives: Biological: IC41 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological assays
Measured: study duration
Secondary outcomes (1)
Safety
Measured: study duration
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 startNov 2002
- Primary completionMay 2004
- Study completionSep 2004
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erich Tauber, M.D., Study director, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602784
- Sponsor's protocol ID
- IC41-201
- Status last verified
- Oct 2012
- First submitted
- 4 Jan 2008
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Multicenter, Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine Together With Polyarginine, HCV Peptide Vaccine Alone, or Polyarginine Alone, in Patients With Chronic HCV Having Not Responded to or Relapsed From Primary Standard HCV Therapy
- ClinicalTrials.gov ID
- NCT00602784
- Acronym / sponsor ID
- IC41-201
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- May 2004 (actual)
- Study completion
- Sep 2004 (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 objectives are
- to determine the immunological profile (CD4+, CD8+ cells, DTH) induced by immunization with HCV antigen peptide vaccine with polyarginine.
- to document virological (HCV-RNA) and biochemical (ALT) responses following immunization with HCV antigen peptide vaccine with polyarginine.
- to assess the safety of immunization with HCV antigen peptide vaccine with polyarginine.
Detailed description
This is a double blind, randomized, parallel group, controlled, multicenter phase II study.
60 patients will be enrolled and assigned to one of the 5 dose or control groups. Each study group will include 8 patients.
Each patient will receive a total of 6 injections according to the dose of the assigned study group. The injections will be administered subcutaneously in the upper arm once every four weeks for 5 months, i.e. at days 1, 29, 57, 85, 113 and 141.
The volume of each injection will be 0.5 ml in all groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| IC41-B-01/02 | Experimental | Biological: IC41peptide dose 0.00 mg, polyarginine dose 2.00 mg |
| IC41-C-01/02 | Experimental | Biological: IC41peptide dose: 5.00 mg, polyarginine dose: 0.00 mg |
| IC41-G-01/02 | Experimental | Biological: IC41peptide dose: 2.50 mg, polyarginine dose: 1.25 mg |
| IC41-H-01/02 | Experimental | Biological: IC41peptide dose: 2.50 mg, polyarginine dose: 2.00 mg |
| IC41-K-01/02 | Experimental | Biological: IC41peptide dose: 5.00 mg, polyarginine dose: 2.00 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of chronic hepatitis C
- Non-response to or relapse from primary standard HCV therapy
- HLA A2 positive
- HCV-RNA positive
- HCV antibodies positive
Key exclusion criteria (16 listed)
- Any degree of liver cirrhosis or fibrosis of Ishak score ≥ 4 (for grading table, see APPENDIX 2: The Ishak Modified Hepatic Activity Index (HAI))
- Any liver disease other than hepatitis C
- History of autoimmune disease
- Immunodeficiency including post-organ-transplantation
- HIV infection
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 |
|---|---|---|
| IC41 | Biological | IC41-B-01/02, IC41-C-01/02, IC41-G-01/02, IC41-H-01/02, IC41-K-01/02 |
Primary outcome
Immunological assays
Time frame: study duration
1 secondary outcome
Safety
Time frame: study duration
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 19 Oct 2012.
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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.
Erich Tauber, M.D. study director
Valneva Austria GmbH
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.
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 10 inclusion and 16 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 19 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Immunological assays (time frame: study duration). 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 19 Oct 2012.