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    Summary
    EudraCT Number:2012-002245-37
    Sponsor's Protocol Code Number:GV28418
    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:2012-10-19
    Trial results View 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 ConcernedGermany - PEI
    A.2EudraCT number2012-002245-37
    A.3Full title of the trial
    A PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF MCMV5322A/MCMV3068A FOR THE PREVENTION OF CYTOMEGALOVIRUS DISEASE IN HIGH-RISK KIDNEY ALLOGRAFT RECIPIENTS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study of MCMV5322A/MCMV3068A in kidney transplant recipients at high risk for CMV disease.
    A.4.1Sponsor's protocol code numberGV28418
    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 SponsorGenentech, Inc.
    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 supportGenentech Inc. c/o F. Hoffmann La Roche Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameMCMV5322A
    D.3.2Product code RO6855849
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.2Current sponsor codeMCMV5322A
    D.3.9.3Other descriptive nameRO6855849
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) No
    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.IMP: 2
    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 nameMCMV3068A
    D.3.2Product code RO6855848
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.2Current sponsor codeMCMV3068A
    D.3.9.3Other descriptive nameRO6855848
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Transplant-associated cytomegalovirus (CMV) infection
    E.1.1.1Medical condition in easily understood language
    Cytomegalovirus (CMV) infection that is associated with kidney transplants.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10011831
    E.1.2Term Cytomegalovirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10058881
    E.1.2Term Cytomegalovirus viremia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level HLGT
    E.1.2Classification code 10047438
    E.1.2Term Viral infectious disorders
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level HLT
    E.1.2Classification code 10011827
    E.1.2Term Cytomegaloviral infections
    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 evaluate the safety of multiple IV doses of MCMV5322A/MCMV3068A given to cytomegalovirus (CMV) seronegative recipients of a renal transplant from a CMV seropositive donor.
    •To determine the clinical activity of multiple IV doses of MCMV5322A/MCMV3068A given to CMV-seronegative recipients of a renal transplant from a CMV-seropositive donor.
    E.2.2Secondary objectives of the trial
    •To characterize the pharmacokinetic (PK) profile of multiple doses of MCMV5322A/MCMV3068A
    •To characterize the immunogenic potential of MCMV5322A/MCMV3068A by measuring anti-MCMV5322A and anti-MCMV3068A antibodies
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patient is scheduled to receive a primary or secondary renal allograft from a living or cadaveric donor.
    •Patient is seronegative for CMV
    •Ability and willingness to provide written informed consent(s) and to comply with the requirements of the protocol
    •Men and women aged > 18 years
    •Female patients of childbearing potential must have negative urine pregnancy test result on Day 1.
    •For women who are not postmenopausal or surgically sterile (defined as
    absence of ovaries and/or uterus): agreement to remain completely
    abstinent or use two methods of contraception at all times
    E.4Principal exclusion criteria
    •Patient is suspected of having CMV disease.
    •Patient is expected to require treatment or prophylaxis with an
    antiviral with anti-CMV activity during the study (e.g., high-dose
    acyclovir, valacyclovir, or famciclovir in patients who are Epstein-Barr
    virus seronegative).
    •Patient has received anti-CMV therapy within the 30 days prior to screening. (Exceptions are the use of acyclovir, valacyclovir, or famciclovir for up to 10 days duration for treatment of acute herpes simplex or herpes zoster or patients receiving acyclovir or valacyclovir at doses to suppress herpes zoster).
    •Patients who have received intravenous immunoglobulin (IVIG) within 3 months before transplantation or with expectation of receiving IVIG at time of transplantation or in the 3 months after transplantation
    •Patients who have received B cell-depleting therapies (rituximab) within 3 months before transplantation or with the expectation of receiving rituximab at the time of transplantation or in the 3 months after transplantation.
    •Patient is receiving a multi-organ transplant (e.g., liver or pancreas in addition to kidney).
    •Active or chronic hepatic or hepatobiliary disease (including known Gilbert’s syndrome) or elevations in a hepatic transaminase (AST or ALT) or bilirubin (total or free) - 2 - upper limit of normal (ULN).
    •Patient is unlikely or unwilling to be available for follow-up for the full 24-week duration of the study.
    •Female patients who are pregnant, plan to become pregnant during the study, or who are breastfeeding
    •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies; fusion proteins; human-derived immunoglobulin preparations; or any constituent of MCMV5322A/MCMV3068A or placebo
    •Active treatment for untreated tuberculosis or other infectious conditions that are significant in the judgment of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    •Detectable CMV viremia within the first 12 weeks after transplantation, defined as at least one CMV viral load > 150 copies/mL as assessed by the central laboratory.
    E.5.1.1Timepoint(s) of evaluation of this end point
    see section E.5.1
    E.5.2Secondary end point(s)
    •Detectable CMV viremia within the first 24 weeks after transplantation, defined as at least one CMV viral load > 150 copies/mL as assessed by the central laboratory.
    •Time to detectable CMV viremia, defined as time from transplant to first CMV viral load >150 copies/mL as assessed by the central laboratory
    •Viral load at first detection of CMV viremia (> 150 copies/mL) as assessed by the central laboratory
    •Peak viral load on or following first detection of CMV viremia (> 150 copies/mL) as assessed by the central laboratory
    •Initiation of preemptive antiviral therapy during the first 12 weeks after transplantation
    •Initiation of preemptive antiviral therapy during the first 24 weeks after transplantation
    •Time to initiation of first use of preemptive antiviral therapy
    •Duration of first use of preemptive antiviral therapy initiated during the first 12 weeks after transplantation
    •Duration of all use of preemptive antiviral therapy initiated during the first 24 weeks after transplantation
    •CMV disease (CMV syndrome or tissue-invasive disease as defined in Appendix 3) during the first 24 weeks after transplantation
    •Change in CMV serostatus as assessed by the central laboratory
    E.5.2.1Timepoint(s) of evaluation of this end point
    See section E.5.2.1
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 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.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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 concerned22
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Belgium
    France
    Germany
    Netherlands
    Norway
    Spain
    Sweden
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 this study is defined as the date when the last patient, last visit (LPLV) occurs or the date at which the last data point required for statistical analysis or safety follow-up is received from the last patient, whichever occurs later. LPLV is expected to occur approximately 6 months after the last patient is enrolled.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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.1.1.1In 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: 115
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 120
    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)
    Genentech does not intend to provide MCMV5322A/MCMV3068A to patients after the conclusion of the study or any earlier withdrawal. Patients may or may not be eligible for any potential subsequent trials of MCMV5322A/MCMV3068A under a separate protocol.
    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 Decision2013-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-15
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