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    Summary
    EudraCT Number:2010-022960-10
    Sponsor's Protocol Code Number:CVC-202
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-11-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2010-022960-10
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety and Efficacy Study of CHRONVAC-C followed by Standard Treatment of Hepatitis C infected Patients.
    A.3.2Name or abbreviated title of the trial where available
    Phase II CHRONVAC-C Study Followed by Standard of Care in Chronic HCV Subjects
    A.4.1Sponsor's protocol code numberCVC-202
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorChronTech Pharma AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInovio Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSemcon Drug Development Consulting
    B.5.2Functional name of contact pointCVC-202 clinical trial information
    B.5.3 Address:
    B.5.3.1Street AddressFältspatvägen 4
    B.5.3.2Town/ cityLund
    B.5.3.3Post code224 78
    B.5.3.4CountrySweden
    B.5.4Telephone number464638 91 02
    B.5.5Fax number4646 270 84 99
    B.5.6E-mailmaria.j.persson@semcon.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameChronVac-C
    D.3.2Product code ChronVac-C
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNChronVac-C
    D.3.9.2Current sponsor codeChronVac-C
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of chronic infections caused by hepatitis C virus genotype 1 strains
    E.1.1.1Medical condition in easily understood language
    Treatment of chronic hepatitis C infections
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the effect of 500 μg plasmid DNA vaccine CHRONVAC-C 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 on early viral kinetics and viral load in treatment naïve chronic HCV genotype 1 subjects with a viral load equal to 1 000 IU/ml or more for further clinical investigations in HCV infected subjects.
    E.2.2Secondary objectives of the trial
    To determine safety, tolerability, and anti-viral immune response (antibodies and IFN-gamma producing T cells) of 500 μg plasmid DNA vaccine CHRONVAC-C 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, in treatment naïve chronic HCV genotype 1 subjects with a viral load equal to 1 000 IU/ml or more.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 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.

    2. Known genotype 1 infection.

    3. Viral load equal to 1000 IU/ml or more

    4. BMI less than 35.

    5. 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.

    6. Written informed consent obtained, and a copy provided to the subject.

    7. Subject legally competent and able to communicate effectively with the study personnel.

    8. Subject likely to co-operate and attend the clinic at the appointed times during the study.
    E.4Principal exclusion criteria
    1. Subject having clinically significant concomitant diseases other than HCV in the medical history to the discretion of the investigator.

    2. Subject having clinically significant findings on physical examination, vital signs, ECG or clinical laboratory evaluations to the discretion of the investigator.

    3. Subject having clinical or biochemical signs of cirrhosis.

    4. Positive hepatitis B surface antigen (HBsAg).

    5. Positive HIV antigen or antibody test.

    6. Subject having an ongoing and/or known viral infection other than HCV that requires treatment and/or special medical intention.

    7. Subject having received previous treatment for HCV.

    8. Radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to the first dose of study drug.

    9. 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.)

    10. Immunization within 30 days of the first dose of the study drug.

    11. 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.

    12. Prior treatment with DNA therapy.

    13. Known allergy towards vaccines.

    14. Known allergy or contraindications to interferon and/or ribavirin or their excipients

    15. Known abuse of alcohol, drugs or pharmaceuticals.

    16. History, signs or symptoms of a cardiac disease.

    17. Presence of an implantable pacemaker.

    18. Any metal implants within the treatment areas (close to the right and/or left deltoid muscles).

    19. Diagnoses of a serious psychiatric illness which may influence study participation.

    20. Female subject who is pregnant or breast feeding.

    21. 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.

    22. Female subject with a positive urine pregnancy test.

    23. Male subject unwilling to use condom for active prevention of pregnancy from first vaccination to 4 months after last injection.

    24. 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.
    E.5 End points
    E.5.1Primary end point(s)
    • HCV-RNA kinetics. Second phase slope of viral decline during the initial 4 weeks of standard of care treatment (Week 2, Week 3 and Week 4) (measured using PCR).

    • Rapid Viral Response (RVR). After 4 weeks of standard of care; Percent subjects reaching non-detectable level of HCV-RNA (measured using PCR).

    • Partial Early Viral Response (pEVR). After 12 weeks of standard of care; Percent HCV-RNA positive subjects with more than 2 log 10 decline in HCV-RNA from standard of care initiation (Week 0) (measured using PCR).

    • Complete Early Viral Response (cEVR). After 12 weeks of standard of care; Percent subjects reaching non-detectable level of HCV-RNA (measured using PCR).

    The HCV-RNA kinetics will be based on analyses of frozen samples while RVR, pEVR, and cEVR will be based on analyses of fresh samples.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints of evaluation are specified in Section E.5.1 above.
    E.5.2Secondary end point(s)
    • Local tolerance will be assessed at the clinic immediately after vaccination, 0.5 h and 2 h after vaccination. The site of injection will also be checked at the following visits.
    • Vital signs will be measured at the clinic before vaccination and 2 h after vaccination. Vital signs are also assessed at Screening, 1st Vaccination (for subjects randomized to CHRONVAC-C treatment), 2nd Vaccination (for subjects randomized to ChronVA-C treatment), Week 0, Week 1, Week 2, Week 3, Week 4, Week 8, and Week 12.
    • AEs will be recorded after active questioning and spontaneous reporting by subject throughout the study, starting in connection with 1st Vaccination for subjects randomized to CHRON-VAC-C treatment and in connection with initiation of SOC for subjects randomized to SOC alone.
    • General blood analyses will be monitored in venous blood at Screening, 1st Vaccination (for subjects randomized to CHRONVAC-C), 2nd Vaccination (for subjects randomized to CHRONVAC-C), Week 0, Week 1, Week 2, Week 3, Week 4, Week 8, and Week 12. At the vaccination visits blood samples will be collected before vaccination.
    • Exploratory Analysis - Characterization and quantification of the vaccine primed NS3-immune response. At Screening, 1st Vaccination (for subjects randomized to CHRONVAC-C treatment), 1st Vaccination + 2 weeks (for subjects randomized to CHRONVAC-C treatment), 2nd Vaccination + 2 weeks (for subjects randomized to CHRONVAC-C treatment), Week 0, Week 2, Week 4, and Week 12. The following parameters will be analyzed in venous blood;
    - HCV NS3 specific antibody levels
    - Activation of NS3/4A-specific T cells
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints of evaluation are specified in Section E. 5.2 above.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Stratification with respect to IL28B
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of trial = Last visit (Week 12) of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 32
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 32
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The subjects participating in this clinical trial will recieve their initial 12 weeks of standard of care for their chronic HCV infection in accordance with the Swedish treatment recommendations during their participation in this clinical trial. The standard of care treatment will continue in accordance to the Swedish treatment recommendations when the patient has ended his/her participation in the trial.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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