Cytomegalovirus InfectionsPhase 3NCT00411645
Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients
A Phase 3 study testing maribavir in people with Cytomegalovirus Infections, run by Shire at 97 sites in 9 countries.
Trial summary
The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- maribavir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 681 participants
- Where
- 97 sitesin 9 countries
- Study dates
- 13 Dec 2006to 23 May 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Allogeneic stem cell transplant recipient
- Recipient or donor CMV seropositive
- Have transplant engraftment
- Able to swallow tablets
Who cannot join
- CMV organ disease
- HIV infection
- Use of other anti-CMV therapy post-transplant
Trial locations and contacts
97 sites in 9 countries.
97 sites in 9 countries
United States56 sites
University of Michigan
Ann Arbor, Michigan, 48109-0914
Emory University
Atlanta, Georgia, 30322
Greenbaum Cancer Center
Baltimore, Maryland, 21201-1595
St Francis Hospital
Beech Grove, Indiana, 46107
Massachusettes General
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599
Northwestern University Medical Center
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
The Jewish Hospital
Cincinnati, Ohio, 45236
Ireland Cancer Center Case Western Reserve University
Cleveland, Ohio, 44106
Baylor University Medical Center
Dallas, Texas, 75246
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Wayne State Medical Center
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
City of Hope Medical Center
Duarte, California, 91010
Duke Medical Center
Durham, North Carolina, 27710
Shands Hospital
Gainesville, Florida, 32610
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
MD Anderson Cancer Center
Houston, Texas, 77030-4009
Methodist Hospital
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Scripps Green Hospital
La Jolla, California, 92037
UCSD Moores Center
La Jolla, California, 92093-0960
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
University of Arkansas Myeloma Institute
Little Rock, Arkansas, 72205
UCLA Medical Center
Los Angeles, California, 90095-1678
University Medical Center University of Louisville Hospital
Louisville, Kentucky, 40202
Loyola University
Maywood, Illinois, 60153
University of Minnesota
Minneapolis, Minnesota, 55455
West Virginia University Hospital
Morgantown, West Virginia, 26506-9162
Vanderbilt Medical Center
Nashville, Tennessee, 37232
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
New York Presbyterian Hospital,Weill Cornell Medical Center
New York, New York, 10021
Mount Sinai Hospital
New York, New York, 10029
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Thomas Jefferson
Philadelphia, Pennsylvania, 19107
Jeanes Hospital - Temple
Philadelphia, Pennsylvania, 19111
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
Oregon Health and Sciences University
Portland, Oregon, 97239-3098
Medical College of Virginia
Richmond, Virginia, 23298
Mayo Clinic College of Medicine
Rochester, Minnesota, 55905
University of Rochester Medical Center
Rochester, New York, 14642
Latter Day Saints Hospital
Salt Lake City, Utah, 84103
Texas Transplant Institute
San Antonio, Texas, 78229
University of California, San Francisco
San Francisco, California, 94143
VA Puget Sound Health Center
Seattle, Washington, 98108
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Wake Forest Medical Center
Winston-Salem, North Carolina, 27157
Germany10 sites
Universitaetsklinikum Koeln, Clinic I for internal Medicine
Cologne, 50937
Univ. Clinic Dresden
Dresden, 01307
University Clinic of Dresden
Dresden, 01307
University of Essen
Essen, 45122
University of Freiburg
Freiburg im Breisgau, 79106
University of Hamburg-Eppendorf
Hamburg, 20246
Hannover, Medizinische Hochschule
Hanover, 30625
University of Heidelberg
Heidelberg, 69120
Johannes-Gutenberg University
Mainz, 55131
University Clinic of Ulm
Ulm, 89081
France6 sites
Hopital Henri Mondor
Créteil, 94010
Edouard Herriot Hopital
Lyon, 69437
Institut Paoli Calmettes
Marseille, 13273
Hopital Hotel Dieu
Nantes, 44093
Hopital St. Louis
Paris, 75475
Hopital Haut-Leveque
Pessac, 33600
Belgium5 sites
ZNA Stuivenberg
Antwerp, 2060
AZ Sint Jan, Department of Hematology
Bruges, 8000
Cliniques Universitaires St,Luc Dept Hematology
Brussels, 1200
UZ Gasthuisberg
Leuven, 3000
CHU Sart -Tilman Department of Medicine, Hematology
Liège, 4000
Canada5 sites
QEII Health Sciences Center
Halifax, Nova Scotia, B3H2Y9
McMaster University Medical Center
Hamilton, Ontario, L8N 3Z5
London Health Sciences Centre
London, Ontario, N6A 4G5
Ottawa General Campus
Ottawa, Ontario, K1H 8L6
Hopital l'Enfant Jesus
Québec, Quebec, G1J 1Z4
Italy5 sites
Careggi University Hospital
Florence, 50134
University of San Martino Hospital
Genova, 16132
San Raffaele del Monte Tabor
Milan, 20132
Pescara Hospital
Pescara, 65123
Bianchi-Melacrino-Morelli Hospital
Reggio Calabria, 89100
Sweden4 sites
Sahlgrenska University Hospital
Gothenburg, S-413 45
Karolinska University Hospital
Huddinge, Stockholm County, 14186
Karolinska University Hospital,Huddinge
Stockholm, 141 86
Akademiska Sjukhuset, Dept Hematology
Uppsala, 751 85
Spain3 sites
Barcelona Hospital
Barcelona, 08036
Duran i Reynals Hospital
Barcelona, 08907
University of Salamanca
Salamanca, E-37007
United Kingdom3 sites
University College Hospital
London, NW1 2BU
Royal Free Hospital
London, NW3 2QG
Hammersmith Hospital
London, W12 OHS
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus Disease in Recipients of Allogeneic Stem Cell Transplants.
The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.
Read the detailed description
Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and efficacy of maribavir for the prevention of CMV disease when given as prophylaxis for up to 12 weeks following allogeneic stem cell transplant.
- Conditions
- Cytomegalovirus Infections
- Being tested
- maribavir, placebo
- Keywords
- prevention, prophylaxis, Cytomegalovirus, CMV, allogeneic stem cell transplant, SCT
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maribavirDrug
100 mg twice daily for up to 12 weeks
placeboOther
twice daily for up to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: maribavir |
| B | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation
All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.
Measured: 6 months post-transplant
Secondary outcomes (10)
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-transplant
All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.
Measured: 6 months post-transplant
Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post- Transplantation
All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease) were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay or (2) CMV DNA polymerase chain reaction (PCR). CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.
Measured: 6 months post-transplant
Number of Participants With Investigator-determined CMV Disease
CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.
Measured: Through 12 months post-transplant (Day 1 to 100 days, 6 months, and 12 months post-transplant)
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation
All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.
Measured: 100 days post-transplant
Number of Participants With EC-confirmed CMV Disease Within 12 Months Post-Transplantation
All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.
Measured: 12 months post-transplant
Percent of Participants With Acute Graft-Versus-Host Disease (GVHD)
Analysis of acute GVHD was based on reported adverse events that mapped to the relevant MedDRA dictionary terms for acute GVHD. The percentage reported is for the occurrence of any grade of acute GVHD.
Measured: Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant)
Percent of Participants With Chronic Graft-Versus-Host Disease (GVHD)
Analysis of chronic GVHD was based on reported adverse events that mapped to the relevant MedDRA dictionary terms for chronic GVHD. The percentage reported is for the occurrence of any grade of chronic GVHD.
Measured: Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant)
Number of Participants Who Died Within 12 Months Post-Transplantation
Measured: Through 12 months post-transplant (Days 1 to 100, 6 months, and 12 months post-transplant)
Plasma Concentration of Maribavir During Treatment
Pharmacokinetic (PK) profile sampling was performed to evaluate plasma concentrations of Maribavir. During the study drug administration period, blood samples for this purpose were collected on Day 7 (Week 1) and at Week 4. Every effort was made to ensure that doses were administered 12 hours apart on the day before and on the day of PK sampling. Permissible assessment windows for PK profile sampling purposes were +/- 3 days and +/- 5 days for the 1- and 4- week samples, respectively. Samples were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. The validated lower limit of quantitation (LLOQ) in plasma was 0.2 μg/mL.
Measured: 12 hours post-dose after 1 and 4 weeks of treatment
Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment
Pharmacokinetic (PK) profile sampling was performed to evaluate plasma concentrations of VP 44469, a metabolite of Maribavir. During the study drug administration period, blood samples for this purpose were collected on Day 7 (Week 1) and at Week 4. Every effort was made to ensure that doses were administered 12 hours apart on the day before and on the day of PK sampling. Permissible assessment windows for PK profile sampling purposes were +/- 3 days and +/- 5 days for the 1- and 4- week samples, respectively. Samples were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. The validated lower limit of quantitation (LLOQ) in plasma was 0.2 μg/mL.
Measured: 12 hours post-dose after 1 and 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2006 (estimated)
- Study start13 Dec 2006
- Primary completion10 Nov 2008
- Study completion23 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionsStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 681 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411645
- Sponsor's protocol ID
- 1263-300
- Other IDs
- 2006-005692-18, SHP620-300
- Status last verified
- Jun 2021
- First submitted
- 12 Dec 2006
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Marty FM, Ljungman P, Papanicolaou GA, Winston DJ, Chemaly RF, Strasfeld L, Young JA, Rodriguez T, Maertens J, Schmitt M, Einsele H, Ferrant A, Lipton JH, Villano SA, Chen H, Boeckh M; Maribavir 1263-300 Clinical Study Group. Maribavir prophylaxis for prevention of cytomegalovirus disease in recipients of allogeneic stem-cell transplants: a phase 3, double-blind, placebo-controlled, randomised trial. Lancet Infect Dis. 2011 Apr;11(4):284-92. doi: 10.1016/S1473-3099(11)70024-X. Epub 2011 Mar 21.
PubMed 21414843
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus Disease in Recipients of Allogeneic Stem Cell Transplants.
- ClinicalTrials.gov ID
- NCT00411645
- Acronym / sponsor ID
- 1263-300
- Conditions
- Cytomegalovirus Infections
- Keywords
- prevention, prophylaxis, Cytomegalovirus, CMV, allogeneic stem cell transplant, SCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 681 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2006 (actual)
- Primary completion
- 10 Nov 2008 (actual)
- Study completion
- 23 May 2009 (actual)
- First posted
- 14 Dec 2006 (estimated)
- Results
- Posted 3 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.
Detailed description
Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and efficacy of maribavir for the prevention of CMV disease when given as prophylaxis for up to 12 weeks following allogeneic stem cell transplant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: maribavir |
| B | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Allogeneic stem cell transplant recipient
- Recipient or donor CMV seropositive
- Have transplant engraftment
- Able to swallow tablets
Key exclusion criteria (3 listed)
- CMV organ disease
- HIV infection
- Use of other anti-CMV therapy post-transplant
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 |
|---|---|---|
| maribavir100 mg twice daily for up to 12 weeks | Drug | A |
| placebotwice daily for up to 12 weeks | Other | B |
Primary outcome
Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation
Time frame: 6 months post-transplant
All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.
10 secondary outcomes
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-transplant
Time frame: 6 months post-transplant
Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post- Transplantation
Time frame: 6 months post-transplant
Number of Participants With Investigator-determined CMV Disease
Time frame: Through 12 months post-transplant (Day 1 to 100 days, 6 months, and 12 months post-transplant)
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation
Time frame: 100 days post-transplant
Number of Participants With EC-confirmed CMV Disease Within 12 Months Post-Transplantation
Time frame: 12 months post-transplant
Percent of Participants With Acute Graft-Versus-Host Disease (GVHD)
Time frame: Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant)
Percent of Participants With Chronic Graft-Versus-Host Disease (GVHD)
Time frame: Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant)
Number of Participants Who Died Within 12 Months Post-Transplantation
Time frame: Through 12 months post-transplant (Days 1 to 100, 6 months, and 12 months post-transplant)
Plasma Concentration of Maribavir During Treatment
Time frame: 12 hours post-dose after 1 and 4 weeks of treatment
Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment
Time frame: 12 hours post-dose after 1 and 4 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21414843Marty FM, Ljungman P, Papanicolaou GA, Winston DJ, Chemaly RF, Strasfeld L, Young JA, Rodriguez T, Maertens J, Schmitt M, Einsele H, Ferrant A, Lipton JH, Villano SA, Chen H, Boeckh M; Maribavir 1263-300 Clinical Study Group. Maribavir prophylaxis for prevention of cytomegalovirus disease in recipients of allogeneic stem-cell transplants: a phase 3, double-blind, placebo-controlled, randomised trial. Lancet Infect Dis. 2011 Apr;11(4):284-92. doi: 10.1016/S1473-3099(11)70024-X. Epub 2011 Mar 21.
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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.
Study Director study director
Takeda
97 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing maribavir in people with Cytomegalovirus Infections, run by Shire at 97 sites in 9 countries.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 sites in United States, Germany, France, Belgium, Canada and 4 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation (time frame: 6 months post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00411645, which also lists 1 linked publication.
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 11 Jun 2021.