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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004729-16 | EudraCT Number | ||
| SHP620-301 | Other Identifier | Shire |
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The purpose of this research study is to investigate whether or not oral maribavir is safe and effective compared to oral ganciclovir for preventing CMV disease when administered for up to 14 weeks in patients who have had a liver transplant.
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 14 weeks following orthotopic liver transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maribavir | Drug | 100mg twice a day for 14 weeks. |
| |
| ganciclovir |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation | All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic 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 polymerase chain reaction [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. | 6 months post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | Incidence of CMV infection or EC-confirmed CMV disease within the 6-month post-transplant period included in this section were defined (1) with infection assessed by pp65 antigenemia assay; (2) with infection assessed by CMV DNA PCR; (3) with infection assessed by either assay (pp65 antigenemia or CMV DNA PCR); and (4) with infection assessed by initiation of anti-CMV therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85006 | United States | ||
| University of California at San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39807668 | Derived | Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4. | |
| 38700045 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Maribavir 100 mg BID | Maribavir: 100mg twice a day (BID) for 14 weeks. |
| FG001 | Ganciclovir 1000 mg TID | Ganciclovir: 1000mg three times per (TID) day for 14 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
1000mg three times per day for 14 weeks. |
|
| 6 months post-transplant |
| Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease) were adjudicated by an independent, blinded EC. CMV infection was assessed by pp65 Antigenemia or CMV DNA PCR from a central or local lab. CMV organ disease was defined as described by Ljungman et al., 2002. | 6 months post-transplant |
| Number of Participants With Investigator-determined CMV Disease | Symptomatic 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 polymerase chain reaction [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. | Through 6 months post-transplant (Day 1 to 100 days and 6 months post-transplant) |
| Number of Participants With EC-confirmed CMV Disease Within 100 Days Post-Transplantation | All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic 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 polymerase chain reaction [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. | 100 days post-transplant |
| Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation | Incidence of CMV infection or EC-confirmed CMV disease within the 6-month post-transplant period included in this section were defined (1) with infection assessed by pp65 antigenemia assay; (2) with infection assessed by CMV DNA PCR; (3) with infection assessed by either assay (pp65 antigenemia or CMV DNA PCR); and (4) with infection assessed by initiation of anti-CMV therapy. | 100 days post-transplant |
| Number of Participants With Retransplantation | Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant) |
| Number of Participants With Graft Failure Related Death | Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant) |
| Number of Participants With Acute Graft Rejection | Rejection was assessed by examining a liver biopsy sample. Diagnosis of graft rejection included a global assessment grade and a rejection activity index score. | 26 weeks post-transplant |
| Number of Participants Who Died Within 6 Months Post-Transplantation | 6 months post-transplant |
| Percent of Participants With Signs of Bone Marrow Suppression | Bone marrow suppression was assessed by the occurrence of adverse events (AEs) of investigator-reported leukopenia, neutropenia, thrombocytopenia, and pancytopenia; absolute neutrophil count (ANC) <1000/mm3; white blood cell (WBC) count toxicity grade shifts from 0-2 at baseline to a maximum of 3-4 post-baseline; and use of hematopoietic growth factors during the 6 month post-transplant period. | 15 weeks |
| Plasma Concentration of Maribavir During Treatment | For the first 16 subjects to have PK profiling performed, PK sampling was collected at Weeks 2, 6 and 10. For subsequent subjects that have PK profiling performed, PK sampling was collected at Weeks 2 and 6. Samples were collected 12 hours after the morning dose of maribavir. Permissible assessment windows for pharmacokinetic profile sampling purposes were +/- 5 days for each sampling day. Samples for determination of maribavir concentration were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. For plasma, the minimum detectable concentration for maribavir was 0.2 μg/mL. | 12 hours post-dose after 2, 6, and 10 weeks of treatment |
| Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment | For the first 16 subjects to have PK profiling performed, PK sampling was collected at Weeks 2, 6 and 10. For subsequent subjects that have PK profiling performed, PK sampling was collected at Weeks 2 and 6. Samples were collected 12 hours after the morning dose of maribavir. Permissible assessment windows for pharmacokinetic profile sampling purposes were +/- 5 days for each sampling day. Samples for determination of VP 44469 (a metabolite of maribavir) concentration were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. For plasma, the minimum detectable concentration for VP 44469 was 0.2 μg/mL. | 12 hours post-dose after 2, 6, and 10 weeks of treatment |
| La Jolla |
| California |
| 92103 |
| United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| University of California at San Francisco | San Francisco | California | 94143 | United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Mayo Clinic College of Medicine | Jacksonville | Florida | 32224 | United States |
| Tampa General | Tampa | Florida | 33606 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern University Medical Center | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | United States |
| Jewish Hospital Louisville | Louisville | Kentucky | 40202 | United States |
| Tulane University Hospital and Clinic | New Orleans | Louisiana | 70112 | United States |
| Ochsner Clinic | New Orleans | Louisiana | 70121 | United States |
| New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Nebraska | Omaha | Nebraska | 68198 | United States |
| University of Medicine and Dentistry of New Jersey | Newark | New Jersey | 07101 | United States |
| NYU School of Medicine | New York | New York | 10016 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Rochester Medical Center- Strong Memorial | Rochester | New York | 14642 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| University of North Carolina, Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| Oregon Health and Sciences University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19104 | United States |
| VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15240 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Methodist Transplant Institute | Memphis | Tennessee | 38104 | United States |
| Baylor University Medical Center (Dallas) | Dallas | Texas | 75246 | United States |
| Baylor College of Medicine (Houston) | Houston | Texas | 77030 | United States |
| Methodist Hospital | Houston | Texas | 77030 | United States |
| UT Memorial Hermann Hospital and Texas Liver Center | Houston | Texas | 77030 | United States |
| University of Texas Health Sciences Center at San Antonio | San Antonio | Texas | 78229 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Univeristy of Washington Medical Center | Seattle | Washington | 98195-7110 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-to-Treat Safety (ITT-S) population, defined as all randomized subjects who received at least one dose of study drug, regardless of whether they had any post-baseline evaluations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Maribavir 100 mg BID | Maribavir: 100mg twice a day (BID) for 14 weeks. |
| BG001 | Ganciclovir 1000 mg TID | Ganciclovir: 1000mg three times per (TID) day for 14 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Distribution of age | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation | All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic 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 polymerase chain reaction [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. | The modified Intent-to-Treat (ITT-M) population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009. | Posted | Number | number of participants with event | 6 months post-transplant |
|
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| Secondary | Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | Incidence of CMV infection or EC-confirmed CMV disease within the 6-month post-transplant period included in this section were defined (1) with infection assessed by pp65 antigenemia assay; (2) with infection assessed by CMV DNA PCR; (3) with infection assessed by either assay (pp65 antigenemia or CMV DNA PCR); and (4) with infection assessed by initiation of anti-CMV therapy. | The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009. | Posted | Number | participants | 6 months post-transplant |
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| Secondary | Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease) were adjudicated by an independent, blinded EC. CMV infection was assessed by pp65 Antigenemia or CMV DNA PCR from a central or local lab. CMV organ disease was defined as described by Ljungman et al., 2002. | The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009. | Posted | Median | Inter-Quartile Range | days | 6 months post-transplant |
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| Secondary | Number of Participants With Investigator-determined CMV Disease | Symptomatic 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 polymerase chain reaction [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. | The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009. | Posted | Number | participants | Through 6 months post-transplant (Day 1 to 100 days and 6 months post-transplant) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With EC-confirmed CMV Disease Within 100 Days Post-Transplantation | All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic 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 polymerase chain reaction [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. | The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009. | Posted | Number | participants | 100 days post-transplant |
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| Secondary | Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation | Incidence of CMV infection or EC-confirmed CMV disease within the 6-month post-transplant period included in this section were defined (1) with infection assessed by pp65 antigenemia assay; (2) with infection assessed by CMV DNA PCR; (3) with infection assessed by either assay (pp65 antigenemia or CMV DNA PCR); and (4) with infection assessed by initiation of anti-CMV therapy. | The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009. | Posted | Number | participants | 100 days post-transplant |
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| Secondary | Number of Participants With Retransplantation | The ITT-Safety (ITT-S) population, defined as all participants who received at least one dose of study drug. | Posted | Number | participants | Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant) |
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| Secondary | Number of Participants With Graft Failure Related Death | The ITT-S population, defined as all participants who received at least one dose of study drug. | Posted | Number | participants | Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant) |
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| Secondary | Number of Participants With Acute Graft Rejection | Rejection was assessed by examining a liver biopsy sample. Diagnosis of graft rejection included a global assessment grade and a rejection activity index score. | The ITT-S population, defined as all participants who received at least one dose of study drug. | Posted | Number | participants | 26 weeks post-transplant |
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| Secondary | Number of Participants Who Died Within 6 Months Post-Transplantation | The ITT-S population, defined as all participants who received at least one dose of study drug. | Posted | Number | participants | 6 months post-transplant |
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| Secondary | Percent of Participants With Signs of Bone Marrow Suppression | Bone marrow suppression was assessed by the occurrence of adverse events (AEs) of investigator-reported leukopenia, neutropenia, thrombocytopenia, and pancytopenia; absolute neutrophil count (ANC) <1000/mm3; white blood cell (WBC) count toxicity grade shifts from 0-2 at baseline to a maximum of 3-4 post-baseline; and use of hematopoietic growth factors during the 6 month post-transplant period. | The ITT-S population, defined as all participants who received at least one dose of study drug. | Posted | Number | percent of participants | 15 weeks |
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| Secondary | Plasma Concentration of Maribavir During Treatment | For the first 16 subjects to have PK profiling performed, PK sampling was collected at Weeks 2, 6 and 10. For subsequent subjects that have PK profiling performed, PK sampling was collected at Weeks 2 and 6. Samples were collected 12 hours after the morning dose of maribavir. Permissible assessment windows for pharmacokinetic profile sampling purposes were +/- 5 days for each sampling day. Samples for determination of maribavir concentration were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. For plasma, the minimum detectable concentration for maribavir was 0.2 μg/mL. | The Pharmacokinetic (PK) population, defined as those participants in the ITT-S population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available. | Posted | Mean | Standard Deviation | μg/mL | 12 hours post-dose after 2, 6, and 10 weeks of treatment |
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| Secondary | Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment | For the first 16 subjects to have PK profiling performed, PK sampling was collected at Weeks 2, 6 and 10. For subsequent subjects that have PK profiling performed, PK sampling was collected at Weeks 2 and 6. Samples were collected 12 hours after the morning dose of maribavir. Permissible assessment windows for pharmacokinetic profile sampling purposes were +/- 5 days for each sampling day. Samples for determination of VP 44469 (a metabolite of maribavir) concentration were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. For plasma, the minimum detectable concentration for VP 44469 was 0.2 μg/mL. | The PK population, defined as those participants in the ITT-S population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available. | Posted | Mean | Standard Deviation | μg/mL | 12 hours post-dose after 2, 6, and 10 weeks of treatment |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Maribavir 100 mg BID | Maribavir: 100mg twice a day (BID) for 14 weeks. | 71 | 147 | 127 | 147 | ||
| EG001 | Ganciclovir 1000 mg TID | Ganciclovir: 1000mg three times per (TID) day for 14 weeks. | 76 | 156 | 140 | 156 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Haemolytic Anaemia | Blood and lymphatic system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Supraventricular Extrasystoles | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Diabetes Mellitus | Endocrine disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Ulcerative Keratitis | Eye disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Abdominal Abscess | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Abdominal Strangulated Hernia | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Clostridium Difficile Colitis | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Diverticulitis | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Fungal Peritonitis | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Intra-Abdominal Haemorrhage | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Obstruction Gastric | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Oesophageal Candidiasis | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Umbilical Hernia | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Alcoholic Liver Disease | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Ascites | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Bile Duct Obstruction | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Bile Duct Stenosis | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Cytolytic Hepatitis | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hepatic Artery Aneurysm | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hepatic Artery Occlusion | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hepatic Artery Stenosis | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hepatic Artery Thrombosis | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hepatic Haematoma | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hepatic Necrosis | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hepatic Steatosis | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hepatitis C | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Liver Abscess | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Portal Hypertension | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Post Procedural Bile Leak | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Acute Graft Versus Host Disease | Immune system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Liver Transplant Rejection | Immune system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Abdominal Sepsis | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
| |
| Bacterial Sepsis | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
| |
| Cytomegalovirus Gastroenteritis | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
| |
| Cytomegalovirus Hepatitis | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
| |
| Cytomegalovirus Infection | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
| |
| Pneumonia Cytomegaloviral | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
| |
| Complications Of Transplanted Liver | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
| |
| Incision Site Cellulitis | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
| |
| Incision Site Pain | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
| |
| Incisional Hernia | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
| |
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
| |
| Postoperative Wound Infection | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
| |
| Therapeutic Agent Toxicity | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
| |
| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
| |
| Wound Infection | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
| |
| Wound Secretion | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
| |
| Band Neutrophil Count Increased | Investigations | MedDRA Version 10.0 | Systematic Assessment |
| |
| Biopsy Liver Abnormal | Investigations | MedDRA Version 10.0 | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA Version 10.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA Version 10.0 | Systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | MedDRA Version 10.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Arthritis Fungal | Musculoskeletal and connective tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Femoral Neck Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Haemorrhage Intracranial | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hypoglycaemic Seizure | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Adjustment Disorder | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Bipolar Disorder | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Mesangioproliferative Glomerulonephritis | Renal and urinary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Nephritis Interstitial | Renal and urinary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Renal and urinary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Lung Neoplasm Malignant | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Pleural Infection | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Pneumonia Staphylococcal | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Respiratory Syncytial Virus Infection | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Arterial Haemorrhage | Vascular disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Syncope | Vascular disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Dysgeusia | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Ascites | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Bile Duct Stenosis | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hepatitis C | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Liver Transplant Rejection | Immune system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA Version 10.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Insomnia | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Renal and urinary disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 10.0 | Systematic Assessment |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C400401 | maribavir |
| D015774 | Ganciclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| 45 to 64 years |
|
| 65 to 75 years |
|
| Cochran-Mantel-Haenszel |
| 0.2754 |
The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe). |
| Odds Ratio (OR) |
| 1.586 |
| 2-Sided |
| 95 |
| 0.682 |
| 3.690 |
| Superiority or Other (legacy) |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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|
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|
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