Trial · NCT02927067
A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants
NCT02927067, Phase 3, Completed, Shire; results first posted 2023-03-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants. Trials, record NCT02927067. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02927067
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants
- NCT number
- NCT02927067
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 553 participants, actual
- Lead sponsor
- Shire
- Conditions
- Cytomegalovirus (CMV)
- Interventions
- Maribavir, Valganciclovir, Placebo
- First posted
- 2016-10-06
- Last updated
- 2023-03-03
- Other registries' IDs
- eudract:2015-004726-34
- Results first posted
- 2023-03-03
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribose Nucleic Acid (DNA) at the End of Study Week 8 | Week 8 | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \<137 International units per milliliter \[IU/mL\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for the primary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed). |
| Secondary | Number of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at the End of Week 8, Followed by Maintenance of Treatment Effect at Week 16 | Week 8 up to Week 16 | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \<137 International units per milliliter \[IU/mL\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this key secondary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed). CMV Infection Symptom Control is defined as no new clinical findings of CMV tissue invasive disease. Maintenance of Treatment Effect is defined as maintaining confirmed CMV viremia clearance and CMV infection symptom control through Week 16. |
| Secondary | Number of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at Week 8 After Receiving 8 Weeks of Study Assigned Treatment | Week 8 | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \<137 International units per milliliter \[IU/mL\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment for 8 weeks. Participants who discontinued treatment early were non-responders for this endpoint. |
| Secondary | Number of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20 | Week 8 through Weeks 12, 16 and 20 | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \<137 International units per milliliter \[IU/mL\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment for 8 weeks. |
| Secondary | Number of Participants Who Maintained Confirmed CMV Viremia Clearance at Week 8 After Receiving Study-Assigned Treatment Through Study Weeks 12 and 20 Regardless of Whether Study Assigned Treatment Was Completed | Week 8 through Weeks 12 and 20 | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \<137 International units per milliliter \[IU/mL\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether the 8-week study-assigned treatment was completed or discontinued early) and had no symptoms of tissue invasive CMV disease at Week 8, Week 8 through Week 12, and Week 8 through Week 20, respectively. |
| Secondary | Number of Participants With Confirmed Recurrence of Viremia During First 8 Weeks of the Study | Up to Week 8 | Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (\>=) lower limit of quantification (LLOQ, i.e. \>=137 International units per milliliter \[IU/mL\]) when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\<LLOQ, i.e. \<137 IU/mL) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study, during the 12 weeks of the follow up study phase, and at any time during the study. |
| Secondary | Number of Participants With Confirmed Recurrence of Viremia During the Follow-up Period | From Week 9 up to Week 20 | Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (\>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\<LLOQ) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study, during the 12 weeks of the follow up study phase, and at any time during the study. |
| Secondary | Number of Participants With Confirmed Recurrence of Viremia at Any Time During the Study | Up to Week 20 | Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (\>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\<LLOQ) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study, during the 12 weeks of the follow up study phase, and at any time during the study. |
| Secondary | Number of Participants With Confirmed Recurrence of Viremia While on Study Treatment and Off Treatment | Baseline up to Week 20 | Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (\>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\<LLOQ) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study, during the 12 weeks of the follow up study phase, and at any time during the study. |
| Secondary | Number of Participants With Grade 3 or 4 (Shift From Baseline Grade <3) and Grade 4 Neutropenia (Shift From Baseline Grade <4) While on Study Treatment | From start of study drug to end of study drug + 1 day (up to approximately Week 8) | Grade 3 and grade 4 neutropenia are defined as absolute neutrophil count (ANC) \<1000 per cubic millimeter (/mm\^3) and ANC \<500/mm\^3 respectively. Incidence of Grade 3 or 4 neutropenia represents the percentage of participants with Grade \<3 (or missing) neutropenia at baseline, but Grade 3 or 4 while on study treatment. Incidence of Grade 4 neutropenia represents the number of participants with Grade \<4 (or missing) neutropenia at baseline, but Grade 4 while on study treatment. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribose Nucleic Acid (DNA) at the End of Study Week 8 | Week 8 | Modified randomized set (i.e., the full analysis set) included all participants in the randomized set who took at least 1 dose of assigned study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at the End of Week 8, Followed by Maintenance of Treatment Effect at Week 16 | Week 8 up to Week 16 | Modified randomized set (i.e., the full analysis set) included all participants in the randomized set who took at least 1 dose of assigned study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at Week 8 After Receiving 8 Weeks of Study Assigned Treatment | Week 8 | Modified randomized set (i.e., the full analysis set) included all participants in the randomized set who took at least 1 dose of assigned study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20 | Week 8 through Weeks 12, 16 and 20 | Modified randomized set (i.e., the full analysis set) included all participants in the randomized set who took at least 1 dose of assigned study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Maintained Confirmed CMV Viremia Clearance at Week 8 After Receiving Study-Assigned Treatment Through Study Weeks 12 and 20 Regardless of Whether Study Assigned Treatment Was Completed | Week 8 through Weeks 12 and 20 | Modified randomized set (i.e., the full analysis set) included all participants in the randomized set who took at least 1 dose of assigned study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Confirmed Recurrence of Viremia During First 8 Weeks of the Study | Up to Week 8 | Overall number analyzed is the subset of participants from the modified randomized set (all participants in the randomized set who took at least 1 dose of study-assigned treatment) who achieved confirmed viremia clearance. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Confirmed Recurrence of Viremia During the Follow-up Period | From Week 9 up to Week 20 | Overall number analyzed is the subset of participants from the modified randomized set (all participants in the randomized set who took at least 1 dose of study-assigned treatment) who achieved confirmed viremia clearance. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Confirmed Recurrence of Viremia at Any Time During the Study | Up to Week 20 | Overall number analyzed is the subset of participants from the modified randomized set (all participants in the randomized set who took at least 1 dose of study-assigned treatment) who achieved confirmed viremia clearance. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Confirmed Recurrence of Viremia While on Study Treatment and Off Treatment | Baseline up to Week 20 | Overall number analyzed is the subset of participants from the modified randomized set (all participants in the randomized set who took at least 1 dose of study-assigned treatment) who achieved confirmed viremia clearance. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Grade 3 or 4 (Shift From Baseline Grade <3) and Grade 4 Neutropenia (Shift From Baseline Grade <4) While on Study Treatment | From start of study drug to end of study drug + 1 day (up to approximately Week 8) | Safety set included all participants who took at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribose Nucleic Acid (DNA) at the End of Study Week 8 | Valganciclovir 900 mg BID | 212 | Participants | ||
| Number of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribose Nucleic Acid (DNA) at the End of Study Week 8 | Maribavir 400 mg BID | 190 | Participants | ||
| Number of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at the End of Week 8, Followed by Maintenance of Treatment Effect at Week 16 | Valganciclovir 900 mg BID | 133 | Participants | ||
| Number of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at the End of Week 8, Followed by Maintenance of Treatment Effect at Week 16 | Maribavir 400 mg BID | 144 | Participants | ||
| Number of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at Week 8 After Receiving 8 Weeks of Study Assigned Treatment | Valganciclovir 900 mg BID | 137 | Participants | ||
| Number of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at Week 8 After Receiving 8 Weeks of Study Assigned Treatment | Maribavir 400 mg BID | 158 | Participants | ||
| Number of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20 | Valganciclovir 900 mg BID | Week 8 | 137 | Participants | |
| Number of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20 | Maribavir 400 mg BID | Week 8 | 158 | Participants | |
| Number of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20 | Valganciclovir 900 mg BID | Week 12 | 98 | Participants | |
| Number of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20 | Maribavir 400 mg BID | Week 12 | 134 | Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Valganciclovir 900 mg BID | 277 | |
| Overall Study | STARTED | Maribavir 400 mg BID | 276 | |
| Overall Study | Treated Participants | Valganciclovir 900 mg BID | 274 | |
| Overall Study | Treated Participants | Maribavir 400 mg BID | 273 | |
| Overall Study | Participants Received 8 Weeks Treatment | Valganciclovir 900 mg BID | 140 | |
| Overall Study | Participants Received 8 Weeks Treatment | Maribavir 400 mg BID | 179 | |
| Overall Study | COMPLETED | Valganciclovir 900 mg BID | 217 | |
| Overall Study | COMPLETED | Maribavir 400 mg BID | 215 | |
| Overall Study | NOT COMPLETED | Valganciclovir 900 mg BID | 60 | |
| Overall Study | NOT COMPLETED | Maribavir 400 mg BID | 61 |
Source ClinicalTrials.gov
Adverse events346
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 | Abdominal pain | Gastrointestinal disorders | Valganciclovir 900 mg BID | 19 | 274 | |
| other | Abdominal pain | Gastrointestinal disorders | Maribavir 400 mg BID | 14 | 273 | |
| other | Acute graft versus host disease in skin | Immune system disorders | Valganciclovir 900 mg BID | 32 | 274 | |
| other | Acute graft versus host disease in skin | Immune system disorders | Maribavir 400 mg BID | 46 | 273 | |
| other | Anaemia | Blood and lymphatic system disorders | Valganciclovir 900 mg BID | 49 | 274 | |
| other | Anaemia | Blood and lymphatic system disorders | Maribavir 400 mg BID | 62 | 273 | |
| other | Asthenia | General disorders | Valganciclovir 900 mg BID | 19 | 274 | |
| other | Asthenia | General disorders | Maribavir 400 mg BID | 13 | 273 | |
| other | Blood creatinine increased | Investigations | Valganciclovir 900 mg BID | 12 | 274 | |
| other | Blood creatinine increased | Investigations | Maribavir 400 mg BID | 18 | 273 |
1 to 10 of 346Source ClinicalTrials.gov
See all 346 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Valganciclovir 900 mg BID | 29 | 277 |
| Total, all-cause mortality | Maribavir 400 mg BID | 37 | 276 |
| Total, other adverse events | Valganciclovir 900 mg BID | 256 | 274 |
| Total, other adverse events | Maribavir 400 mg BID | 245 | 273 |
| Total, serious adverse events | Valganciclovir 900 mg BID | 95 | 274 |
| Total, serious adverse events | Maribavir 400 mg BID | 88 | 273 |
Source ClinicalTrials.gov
Papers3
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 comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Valganciclovir 900 mg BID vs Maribavir 400 mg BID: Number of Participants With Confirmed Recurrence of Viremia During the Follow-up Period | Trial comparisons |
Valganciclovir 900 mg BID vs Maribavir 400 mg BID: Number of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at the End of Week 8, Followed by Maintenance of Treatment Effect at Week 16 | Trial comparisons |
| Valganciclovir 900 mg BID vs Maribavir 400 mg BID: Number of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribose Nucleic Acid (DNA) at the End of Study Week 8 | Trial comparisons |
| Valganciclovir 900 mg BID vs Maribavir 400 mg BID: Number of Participants Developing Resistance | Trial comparisons |
| Valganciclovir 900 mg BID vs Maribavir 400 mg BID: Number of Participants With Confirmed Recurrence of Viremia at Any Time During the Study | Trial comparisons |
| Valganciclovir 900 mg BID vs Maribavir 400 mg BID: Number of Participants With Confirmed Recurrence of Viremia During First 8 Weeks of the Study | Trial comparisons |
Valganciclovir 900 mg BID vs Maribavir 400 mg BID: Number of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at Week 8 After Receiving 8 Weeks of Study Assigned Treatment | Trial comparisons |
| Valganciclovir 900 mg BID vs Maribavir 400 mg BID: deaths from any cause | Trial comparisons |
| Valganciclovir 900 mg BID vs Maribavir 400 mg BID: Number of Participants With Treatment-Emergent Adverse Events During the On-Treatment Period | Trial comparisons |
| Valganciclovir 900 mg BID vs Maribavir 400 mg BID: 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.
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