Trial · NCT00497796
Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients
NCT00497796, Phase 3, Completed, Shire; results first posted 2015-06-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients. Trials, record NCT00497796. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00497796
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients
- NCT number
- NCT00497796
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 307 participants, actual
- Lead sponsor
- Shire
- Conditions
- Cytomegalovirus Infections
- Interventions
- maribavir, ganciclovir
- First posted
- 2007-07-09
- Last updated
- 2021-06-11
- Other registries' IDs
- eudract:2007-004729-16
- Results first posted
- 2015-06-04
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation | 6 months post-transplant | 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. |
| Secondary | Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | 6 months post-transplant | 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. |
| Secondary | Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | 6 months post-transplant | 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. |
| Secondary | Number of Participants With Investigator-determined CMV Disease | Through 6 months post-transplant (Day 1 to 100 days and 6 months post-transplant) | 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. |
| Secondary | Number of Participants With EC-confirmed CMV Disease Within 100 Days Post-Transplantation | 100 days post-transplant | 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. |
| Secondary | Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation | 100 days post-transplant | 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. |
| Secondary | Number of Participants With Retransplantation | Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant) | |
| Secondary | Number of Participants With Graft Failure Related Death | Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant) | |
| Secondary | Number of Participants With Acute Graft Rejection | 26 weeks post-transplant | Rejection was assessed by examining a liver biopsy sample. Diagnosis of graft rejection included a global assessment grade and a rejection activity index score. |
| Secondary | Number of Participants Who Died Within 6 Months Post-Transplantation | 6 months post-transplant |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation | 6 months post-transplant | 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. | number of participants with event | NUMBER |
| SECONDARY | Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | 6 months post-transplant | 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. | participants | NUMBER |
| SECONDARY | Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | 6 months post-transplant | 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. | days | MEDIAN |
| SECONDARY | Number of Participants With Investigator-determined CMV Disease | Through 6 months post-transplant (Day 1 to 100 days and 6 months post-transplant) | 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. | participants | NUMBER |
| SECONDARY | Number of Participants With EC-confirmed CMV Disease Within 100 Days Post-Transplantation | 100 days post-transplant | 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. | participants | NUMBER |
| SECONDARY | Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation | 100 days post-transplant | 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. | participants | NUMBER |
| SECONDARY | Number of Participants With Retransplantation | Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant) | The ITT-Safety (ITT-S) population, defined as all participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Graft Failure Related Death | Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant) | The ITT-S population, defined as all participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Acute Graft Rejection | 26 weeks post-transplant | The ITT-S population, defined as all participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants Who Died Within 6 Months Post-Transplantation | 6 months post-transplant | The ITT-S population, defined as all participants who received at least one dose of study drug. | participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation | Maribavir 100 mg BID | 14 | number of participants with event | ||
| Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation | Ganciclovir 1000 mg TID | 10 | number of participants with event | ||
| Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | Maribavir 100 mg BID | pp65 antigenemia assay | 63 | participants | |
| Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | Ganciclovir 1000 mg TID | pp65 antigenemia assay | 49 | participants | |
| Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | Maribavir 100 mg BID | CMV DNA PCR assay | 72 | participants | |
| Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | Ganciclovir 1000 mg TID | CMV DNA PCR assay | 52 | participants | |
| Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | Maribavir 100 mg BID | pp65 antigenemia or CMV DNA PCR assay | 81 | participants | |
| Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | Ganciclovir 1000 mg TID | pp65 antigenemia or CMV DNA PCR assay | 64 | participants | |
| Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | Maribavir 100 mg BID | Initiation of anti-CMV therapy | 46 | participants | |
| Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation | Ganciclovir 1000 mg TID | Initiation of anti-CMV therapy | 39 | participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Maribavir 100 mg BID | 147 | |
| Overall Study | STARTED | Ganciclovir 1000 mg TID | 160 | |
| Overall Study | COMPLETED | Maribavir 100 mg BID | 62 | |
| Overall Study | COMPLETED | Ganciclovir 1000 mg TID | 101 | |
| Overall Study | NOT COMPLETED | Maribavir 100 mg BID | 85 | |
| Overall Study | NOT COMPLETED | Ganciclovir 1000 mg TID | 59 |
Source ClinicalTrials.gov
Adverse events348
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Maribavir 100 mg BID | 9 | 147 | |
| other | Anaemia | Blood and lymphatic system disorders | Ganciclovir 1000 mg TID | 13 | 156 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Maribavir 100 mg BID | 8 | 147 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Ganciclovir 1000 mg TID | 5 | 156 | |
| other | Leukopenia | Blood and lymphatic system disorders | Maribavir 100 mg BID | 12 | 147 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ganciclovir 1000 mg TID | 19 | 156 | |
| other | Neutropenia | Blood and lymphatic system disorders | Maribavir 100 mg BID | 8 | 147 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ganciclovir 1000 mg TID | 10 | 156 | |
| other | Abdominal Distension | Gastrointestinal disorders | Maribavir 100 mg BID | 0 | 147 | |
| other | Abdominal Distension | Gastrointestinal disorders | Ganciclovir 1000 mg TID | 8 | 156 |
1 to 10 of 348Source ClinicalTrials.gov
See all 348 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Maribavir 100 mg BID | ||
| Total, all-cause mortality | Ganciclovir 1000 mg TID | ||
| Total, other adverse events | Maribavir 100 mg BID | 127 | 147 |
| Total, other adverse events | Ganciclovir 1000 mg TID | 140 | 156 |
| Total, serious adverse events | Maribavir 100 mg BID | 71 | 147 |
| Total, serious adverse events | Ganciclovir 1000 mg TID | 76 | 156 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Maribavir 100 mg BID vs Ganciclovir 1000 mg TID: Number of Participants With EC-confirmed CMV Disease Within 100 Days Post-Transplantation | Trial comparisons |
| Maribavir 100 mg BID vs Ganciclovir 1000 mg TID: Number of Participants Who Died Within 6 Months Post-Transplantation | Trial comparisons |
| Maribavir 100 mg BID vs Ganciclovir 1000 mg TID: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00497796
GET https://conductscience.org/api/trials/v1/NCT00497796/results?page=2