Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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28 February 2019 |
Main ID: |
EUCTR2012-002245-37-GB |
Date of registration:
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19/09/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Clinical study of MCMV5322A/MCMV3068A in kidney transplant recipients at high risk for CMV disease.
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Scientific title:
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A PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF MCMV5322A/MCMV3068A FOR THE PREVENTION OF CYTOMEGALOVIRUS DISEASE IN HIGH-RISK KIDNEY ALLOGRAFT RECIPIENTS |
Date of first enrolment:
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16/11/2012 |
Target sample size:
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110 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002245-37 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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France
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Germany
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Netherlands
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Norway
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Spain
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Sweden
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United Kingdom
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United States
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Contacts
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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Genentech Inc. c/o F. Hoffmann La Roche Ltd. |
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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Genentech Inc. c/o F. Hoffmann La Roche Ltd. |
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Key inclusion & exclusion criteria
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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
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria: •Patient is suspected of having CMV disease.
•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 or fusion proteins or human-derived immunoglobulin preparations
•Active treatment for untreated tuberculosis or other infectious conditions that are significant in the judgment of the investigator
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Virus Diseases [C02]
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Transplant-associated cytomegalovirus (CMV) infection
MedDRA version: 20.1
Level: PT
Classification code 10011831
Term: Cytomegalovirus infection
System Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.1
Level: LLT
Classification code 10058881
Term: Cytomegalovirus viremia
System Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0
Level: HLGT
Classification code 10047438
Term: Viral infectious disorders
System Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0
Level: SOC
Classification code 10021881
Term: Infections and infestations
System Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0
Level: HLT
Classification code 10011827
Term: Cytomegaloviral infections
System Organ Class: 10021881 - Infections and infestations
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Intervention(s)
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Product Name: MCMV5322A Product Code: RO6855849 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: N/A Current Sponsor code: MCMV5322A Other descriptive name: RO6855849 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use
Product Name: MCMV3068A Product Code: RO6855848 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: N/A Current Sponsor code: MCMV3068A Other descriptive name: RO6855848 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Main Objective: •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.
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Secondary Objective: •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
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Primary 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.
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Timepoint(s) of evaluation of this end point: see section E.5.1
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: See section E.5.2.1
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Secondary 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
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Secondary ID(s)
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GV28418
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2012-002245-37-NO
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Source(s) of Monetary Support
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Genentech Inc. c/o F. Hoffmann La Roche Ltd.
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Ethics review
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Status: Approved
Approval date:
Contact:
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