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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42732   clinical trials with a EudraCT protocol, of which   7035   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2013-000464-29
    Sponsor's Protocol Code Number:0113-CL-2001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-03
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2013-000464-29
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ from a CMV-Seropositive Donor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)- Seronegative Kidney Transplant Recipients Receiving an Organ from a CMV-Seropositive Donor, when compared against placebo in a randomised, double blind manner.
    A.4.1Sponsor's protocol code number0113-CL-2001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01974206
    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 SponsorAstellas Pharma Global Development, Inc. (APGD)
    B.1.3.4CountryUnited States
    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 supportAstellas Pharma Global Development, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V. - Global Development Operations
    B.5.2Functional name of contact pointService Desk
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.4Telephone number 0031 071 545 5878
    B.5.5Fax number0031 071 545 5224
    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 Yes
    D.2.5.1Orphan drug designation numberEU /3/12/1042
    D.3 Description of the IMP
    D.3.2Product code ASP0113
    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 INNnot available
    D.3.9.1CAS number 1498125-70-4
    D.3.9.2Current sponsor codeASP0113, VCL-CB01, bivalent vaccine
    D.3.9.3Other descriptive nameCovalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes.
    D.3.9.4EV Substance CodeSUB88620
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    CMV reactivation after Kidney Transplantation Receiving an Organ from a CMV-Seropositive Donor
    E.1.1.1Medical condition in easily understood language
    CMV infection, disease, and related complications occuring in people after Kidney Transplantation
    Receiving an Organ from a CMV-Seropositive Donor
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10049107
    E.1.2Term CMV viraemia
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of CMV viremia (defined as plasma viral load ≥ 1000 IU/mL by central laboratory assay) through one year post first Study Drug injection in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of ASP0113 in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomics Sub-Study,
    The retrospective pharmacogenomic research that will be conducted in the future with acquired blood samples is exploratory. The objective of this research is to comprehensively analyze:
    • Suspected disease-related genes.
    • Genes of relevance to clinical response, pharmacokinetics, and
    toxicity/safety issues, to be identified in a precautionary/retrospective setting.
    E.3Principal inclusion criteria
    1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability (HIPAA) Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-specific procedures (including withdrawal of prohibited medication, if applicable).
    2. Subject is willing to comply with the protocol.
    3. Subject is ≥ 18 years of age or the legal age of consent (whichever is greater).
    4. Subject is CMV-seronegative at time of transplant and has received a kidney from a CMVseropositive living or deceased donor. CMV serostatus of the recipient can be determined from 8 weeks prior to transplant, by local laboratory, through day of transplantation. If CMV serostatus is not available from this time period, CMV serostatus may be assessed at the Screening Visit, by local laboratory, with results available prior to Randomization.
    5. Subject started valganciclovir or ganciclovir within 10 days of transplant and has received it through Randomization, per regulatory label (package insert).
    6. Female subject must be either:
    * Of non child-bearing potential:
    o post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
    o documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening).
    * Or, if of childbearing potential:
    o must have a negative urine pregnancy test at Screening, and
    o if heterosexually active must use two forms of birth control* (at least one of which must be a barrier method) starting at Screening and during the Primary Study Period.
    7. Female subject must not be breastfeeding at Screening and during the Primary Study Period.
    8. Female subject must not donate ova starting at Screening and during the Primary Study Period.
    9. Male subject and his female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control* (one of which must be a barrier method) starting at Screening and during the Primary Study Period .
    *Acceptable forms of birth control include:
    * Established use of oral, injected or implanted hormonal methods of contraception.
    * Placement of intrauterine device (IUD) or intrauterine system (IUS).
    * Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
    * Partner male sterilization (i.e., vasectomy)
    10. Male subject must not donate sperm starting at Screening and during the Primary Study Period.
    11. Subject agrees not to participate in another interventional drug study while on treatment.
    E.4Principal exclusion criteria
    1. Subject is planned to undergo a course of CMV-specific prophylactic therapy with antiviral drugs with a duration of greater than 100 days.
    2. Subject has received from one month prior to transplant or is planning to receive CMV immunoglobulin.
    3. Subject has had CMV viremia or CMV disease from time of transplant until time of Randomization.
    4. Subject has received, at any time, an organ transplant other than a kidney. (Dual allocation of a kidney is acceptable).
    5. Subject requires dialysis on the day of Randomization.
    6. Recipient or donor is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis B core IgM or IgG antibody.
    7. Subject is known to have latent or active tuberculosis which has not been adequately treated.
    8. Subject required desensitization for ABO blood type incompatibility or a positive T or B cell crossmatch.
    9. Subject has received any of the following substances or treatments:
    a. Investigational research products within 28 days or 5 half lives whichever is longer, prior toTransplantation, or subject is scheduled to receive investigational research products through one year after Randomization.
    b. Alemtuzumab within 90 days prior to Randomization or is scheduled to receive alemtuzumab any time through one year post Randomization.
    c. Rituximab within 120 days prior to Randomization or is scheduled to receive rituximab any time through one year post Randomization.
    d. Eculizumab or bortezomib from the Day of Transplantation through the Day of Randomization or is scheduled to receive eculizumab or bortezomib any time through one year post Randomization.
    e. IVIG and/or plasmapheresis from Day of Transplant through Day of Randomization.
    f. Live attenuated vaccines within one month (30 days) prior to the first dose of Study Drug or is scheduled to receive live attenuated vaccines within one month of any Study Drug injection.
    g. Subunit or killed vaccines within 14 days prior to the first dose of Study Drug or is scheduled to receive a subunit or killed vaccine within 14 days prior to any Study Drug injection.
    h. Administration of a CMV vaccine, including any prior exposure to ASP0113.
    i. Subject has received the following anti-viral therapies or it is planned for them to receive the AVT for prophylaxis of viral infections in excess of the following doses from time of transplant through Randomization:
    * Aciclovir: 1600 mg orally (total daily dose), or 500 mg/m2/dose Intravenous (IV) (total daily dose)
    * Valaciclovir: 1000 mg orally (total daily dose)
    * Famciclovir: 500 mg orally (total daily dose)
    10. Subject has received any anticoagulants including, but not limited to, vitamin K antagonists, heparin or its derivatives, low molecular weight heparin, factor X inhibitors, or thrombin inhibitors within 5 half-lives prior to Randomization or is expected to use anticoagulants within 5 half-lives prior to any Study Drug injection. Low dose anticoagulants that are used for prevention of deep vein thrombosis and antiplatelet agents are allowed.
    11. Subject has any contraindication to or cannot be dosed with valganciclovir or ganciclovir per package insert on the Day of Randomization for any reason.
    12.Subject has, or is expected to have during the Primary Study Period, a contraindication to an intramuscular injection.
    13. Subject, within 3 days prior to Randomization, has an Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) greater than 3 x Upper Limits of Normal (ULN) or total bilirubin greater than 2 x ULN unless secondary to suspected Gilbert’s disease.
    14. Subject has a current malignancy or a recent history of malignancy (within the past 5 years prior to Screening) except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully or cancer in situ of the cervix uteri that has been successfully treated by local therapy.
    15. Subject is being treated for an active infection at the time of Randomization.
    16. Subject has any condition or an unstable medical or psychiatric condition, including a history of illicit drug(s) or alcohol abuse that the Investigator believes will place the subject at unacceptable risk or interfere with compliance to protocol requirements.
    17. The subject has any other condition which, in the opinion of the Investigator, precludes the subjects participation in the trial.
    18. Subject has known allergies or previous adverse reactions to ganciclovir or valganciclovir.
    19. Subject has had an allergic reaction to any component of the vaccine, including aminoglycosides, as kanamycin is used during the manufacturing process of the vaccine.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of CMV viremia (defined as plasma viral load of ≥ 1000 IU/mL by central assay) through one year post first Study Drug injection.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through one year post-transplant.
    E.5.2Secondary end point(s)
    Incidence of:
    * Adjudicated CMV disease, including CMV syndrome and CMV tissue-invasive disease through one year post first Study Drug injection.
    * CMV viremia (defined as plasma viral load ≥ the lower limit of quantification [LOQ]) by central assay through one year post first Study Drug injection.
    * Adjudicated CMV-specific antiviral therapy for the treatment of CMV viremia or disease through one year post first Study Drug injection.
    * Graft survival through one year post first Study Drug injection.
    * Subject survival through one year post first Study Drug injection.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through one year post-transplant.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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. 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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
    The end of trial in all participating countries is defined as the Last Subject’s Last Visit at the end of the Primary Study Period (Day 395). The Long Term Follow Up will continue after the end of trials’ Primary Study Period.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 140
    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)
    Subjects will be contacted by telephone at 6 months after Day 395, then annually for the next 4 years for long-term safety related to the DNA vaccine. Items to be assessed by questionnaire and available patient records include mortality, development of any new cancer, development of infection requiring hospitalization or resulting in death, graft survival, creatinine and erythema and/or induration at the sites of immunizations.
    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 Decision2014-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
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