Chronic Hepatitis CPhase 2NCT01335711
CHRONVAC-C Study Followed by Standard of Care in Chronic Hepatitis C Virus (HCV) Subjects
A Phase 2 study testing ChronVac-C + SOC and SOC in people with Chronic Hepatitis C, run by ChronTech Pharma AB at 2 sites in Sweden.
Trial summary
To explore the effect on early viral kinetics and viral load, and to determine safety, tolerability and anti-viral response for the plasmid DNA vaccine CHRONVAC-C administered i.m. in combination with electroporation followed by standard of care (SOC) in treatment naïve chronic HCV genotype 1 patients. 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?
- ChronVac-C + SOC and SOC
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesSweden
- Study dates
- Apr 2011to Jun 2012
- 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
- Male or female subject 18 - 65 years of age with a known chronic hepatitis C infection, being treatment naїve (that is not being earlier treated for HCV infection) and a planned start of standard of care within 12 weeks from screening.
- Known genotype 1 infection.
- Viral load equal to 1000 IU/ml or more
- BMI less than 35.
- Considered probable that the deltoid muscles (left and right) of the subject will be reached at vaccination using a 12.7 mm cannula for injection and a 15 mm applicator tip for electroporation.
- Written informed consent obtained, and a copy provided to the subject.
- Subject legally competent and able to communicate effectively with the study personnel.
- Subject likely to co-operate and attend the clinic at the appointed times during the study
Who cannot join
- Subject having clinically significant concomitant diseases other than HCV in the medical history to the discretion of the investigator.
- Subject having clinically significant findings on physical examination, vital signs, ECG or clinical laboratory evaluations to the discretion of the investigator.
- Subject having clinical or biochemical signs of cirrhosis.
- Positive hepatitis B surface antigen (HBsAg).
- Positive HIV antigen or antibody test.
- Subject having an ongoing and/or known viral infection other than HCV that requires treatment and/or special medical intention.
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- Subject having received previous treatment for HCV.
- Radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to the first dose of study drug.
- Treatment with immunomodulating agents such as systemic corticosteroids, IL-2, IFN-alpha, IFN-beta, IFN-gamma within 4 weeks prior to the first dose of study drug. (Corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are allowed, however not on the vaccination area.)
- Immunization within 30 days of the first dose of the study drug.
- Subject having received an investigational drug product, or been enrolled in other investigational drug protocols within a period of 30 days prior to receiving the first dose of the study drug.
- Prior treatment with DNA therapy.
- Known allergy towards vaccines.
- Known allergy or contraindications to interferon and/or ribavirin or their excipients
- Known abuse of alcohol, drugs or pharmaceuticals.
- History, signs or symptoms of a cardiac disease.
- Presence of an implantable pacemaker.
- Any metal implants within the treatment areas (close to the right and/or left deltoid muscles).
- Diagnoses of a serious psychiatric illness which may influence study participation.
- Female subject who is pregnant or breast feeding.
- Female subject not clinically sterile (hysterectomy, tubal ligation or postmenopausal (amenorrhea > 1 year and FSH > 30 mU/ml) OR if not clinically sterile unwilling to use a reliable contraception method.
- Female subject with a positive urine pregnancy test.
- Male subject unwilling to use condom for active prevention of pregnancy from first vaccination to 4 months after last injection.
- Subject or their immediate families being an investigator or site personnel directly affiliated with this study. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Recruiting
I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital
Huddinge, SE-141 86
Ola RH Weiland, Professor, +46 (8) 585 800 00, ola.weiland@ki.se
Ola RH Weiland, Professor
- Recruiting
Division of Infectious Diseases, Department of Clinical and experimental medicine, Faculty of Health Sciences, Linköping University, Department of Infectious Diseases, County Council of Östergötland
Linköping, SE-581 85
Kristina Cardell, MD, +46 (0)10 103 00 00, kristina.cardell@lio.se
Kristina Cardell, MD
About this study
Official title: A Phase II Open-Label, Randomized, Parallel Group, Safety, Tolerability and Efficacy Study of i.m. Administered CHRONVAC-C in Combination With Electroporation Followed by Standard of Care in Chronic Hepatitis C Virus Genotype 1 Infected and Treatment Naïve Subjects
To explore the effect on early viral kinetics and viral load, and to determine safety, tolerability and anti-viral response for the plasmid DNA vaccine CHRONVAC-C administered i.m. in combination with electroporation followed by standard of care (SOC) in treatment naïve chronic HCV genotype 1 patients.
- Conditions
- Chronic Hepatitis C
- Being tested
- ChronVac-C + SOC, SOC
- 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.
ChronVac-C + SOCDrug
IMP: I.m. administration of 500 μg plasmid DNA vaccine CHRONVAC-C (solution for injection) administered i.m. in combination with electroporation using MedPulser® DDS on 2 occasions with 4 weeks in between followed by standard of care (SOC) initiation after 14 - 42 days.
SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of < 75 kg and 1200 mg/day for subjects with a BW of > 75 kg)
SOCDrug
SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of < 75 kg and 1200 mg/day for subjects with a BW of > 75 kg)
| Study group | Role | What they receive |
|---|---|---|
| IMP_C/C IL28B | Experimental | C/C IL28B subjects to whom IMP will be administrated prior to SOC Receives: Drug: ChronVac-C + SOC |
| SOC_C/C IL28B | Active comparator | C/C IL28B subjects to whom only SOC will be administrated Receives: Drug: SOC |
| IMP_non-C/C IL28B | Experimental | non-C/C IL28B subjects to whom IMP will be administrated prior to SOC Receives: Drug: ChronVac-C + SOC |
| SOC_non-C/C IL28B | Active comparator | non-C/C IL28B subjects to whom only SOC will be administrated Receives: Drug: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early viral kinetics - Second phase slope of viral decline
Measured: 0-4 weeks after SOC onset
Rapid Viral Response (RVR). Percent subjects reaching non-detectable level of HCV-RNA.
Measured: 4 weeks after SOC onset
Partial Early Viral Response (pEVR). Percent HCV-RNA positive subjects with more than 2 log 10 decline in HCV-RNA.
Measured: 12 weeks after SOC onset
Complete Early Viral Response (cEVR). Percent subjects reaching non-detectable level of HCV-RNA.
Measured: 12 weeks after SOC onset
Secondary outcomes (5)
Local tolerance
Local tolerance will be measured for subjects randomized to vaccination. Local tolerance will be measured 3 times during a time period of 2 h post vaccination. The site of injection will also be inspected at the following visits.
Measured: up to 12 weeks after SOC onset
Change from baseline in vital signs
Measured: 0 - 12 weeks
Number of patients with AEs
Measured: 12 weeks
Change of blood status from baseline
Measured: 0 - 12 weeks
Exploratory Analysis - Characterization and quantification of the vaccine primed NS3-immune response
Measured: 0 - 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
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
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChronTech Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inovio Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Ola RH Weiland, Professor, Principal investigator, I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge, SwedenAnders G Vahlne, Professor, Study chair, ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, SwedenMatti Sällberg, Professor, Study director, ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335711
- Sponsor's protocol ID
- CVC-202
- Other IDs
- 2010-022960-10
- Status last verified
- Oct 2011
- First submitted
- 13 Apr 2011
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-Label, Randomized, Parallel Group, Safety, Tolerability and Efficacy Study of i.m. Administered CHRONVAC-C in Combination With Electroporation Followed by Standard of Care in Chronic Hepatitis C Virus Genotype 1 Infected and Treatment Naïve Subjects
- ClinicalTrials.gov ID
- NCT01335711
- Acronym / sponsor ID
- CVC-202
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- ChronTech Pharma ABIndustry (pharma, biotech, devices)
- Collaborators
- Inovio Pharmaceuticals
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 14 Apr 2011 (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.
To explore the effect on early viral kinetics and viral load, and to determine safety, tolerability and anti-viral response for the plasmid DNA vaccine CHRONVAC-C administered i.m. in combination with electroporation followed by standard of care (SOC) in treatment naïve chronic HCV genotype 1 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IMP_C/C IL28B | Experimental | Drug: ChronVac-C + SOCC/C IL28B subjects to whom IMP will be administrated prior to SOC |
| SOC_C/C IL28B | Active comparator | Drug: SOCC/C IL28B subjects to whom only SOC will be administrated |
| IMP_non-C/C IL28B | Experimental | Drug: ChronVac-C + SOCnon-C/C IL28B subjects to whom IMP will be administrated prior to SOC |
| SOC_non-C/C IL28B | Active comparator | Drug: SOCnon-C/C IL28B subjects to whom only SOC will be administrated |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subject 18 - 65 years of age with a known chronic hepatitis C infection, being treatment naїve (that is not being earlier treated for HCV infection) and a planned start of standard of care within 12 weeks from screening.
- Known genotype 1 infection.
- Viral load equal to 1000 IU/ml or more
- BMI less than 35.
- Considered probable that the deltoid muscles (left and right) of the subject will be reached at vaccination using a 12.7 mm cannula for injection and a 15 mm applicator tip for electroporation.
Key exclusion criteria (24 listed)
- Subject having clinically significant concomitant diseases other than HCV in the medical history to the discretion of the investigator.
- Subject having clinically significant findings on physical examination, vital signs, ECG or clinical laboratory evaluations to the discretion of the investigator.
- Subject having clinical or biochemical signs of cirrhosis.
- Positive hepatitis B surface antigen (HBsAg).
- Positive HIV antigen or antibody test.
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 |
|---|---|---|
| ChronVac-C + SOCIMP: I.m. administration of 500 μg plasmid DNA vaccine CHRONVAC-C (solution for injection) administered i.m. in combination with electroporation using MedPulser® DDS on 2 occasions with 4 weeks in between followed by standard of care (SOC) initiation after 14 - 42 days. SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of < 75 kg and 1200 mg/day for subjects with a BW of > 75 kg) | Drug | IMP_C/C IL28B, IMP_non-C/C IL28B |
| SOCSOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of < 75 kg and 1200 mg/day for subjects with a BW of > 75 kg) | Drug | SOC_C/C IL28B, SOC_non-C/C IL28B |
Primary outcome
Early viral kinetics - Second phase slope of viral decline
Time frame: 0-4 weeks after SOC onset
Rapid Viral Response (RVR). Percent subjects reaching non-detectable level of HCV-RNA.
Time frame: 4 weeks after SOC onset
Partial Early Viral Response (pEVR). Percent HCV-RNA positive subjects with more than 2 log 10 decline in HCV-RNA.
Time frame: 12 weeks after SOC onset
Complete Early Viral Response (cEVR). Percent subjects reaching non-detectable level of HCV-RNA.
Time frame: 12 weeks after SOC onset
5 secondary outcomes
Local tolerance
Time frame: up to 12 weeks after SOC onset
Change from baseline in vital signs
Time frame: 0 - 12 weeks
Number of patients with AEs
Time frame: 12 weeks
Change of blood status from baseline
Time frame: 0 - 12 weeks
Exploratory Analysis - Characterization and quantification of the vaccine primed NS3-immune response
Time frame: 0 - 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
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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.
Ola RH Weiland, Professor principal investigator
I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge, Sweden
Anders G Vahlne, Professor study chair
ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden
Matti Sällberg, Professor study director
ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ChronVac-C + SOC and SOC in people with Chronic Hepatitis C, run by ChronTech Pharma AB at 2 sites in Sweden.
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 24 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: status not confirmed, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ola RH Weiland, Professor (+46 (8) 585 800 00, ola.weiland@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early viral kinetics - Second phase slope of viral decline (time frame: 0-4 weeks after SOC onset). The study lists 4 primary outcomes in all. 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 12 Oct 2011.