Trial · NCT02931539
Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
NCT02931539, Phase 3, Completed, Shire; results first posted 2021-09-23
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir. Trials, record NCT02931539. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02931539
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
- NCT number
- NCT02931539
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 352 participants, actual
- Lead sponsor
- Shire
- Conditions
- Cytomegalovirus (CMV)
- Interventions
- Maribavir, Ganciclovir, Valganciclovir, Foscarnet, Cidofovir
- First posted
- 2016-10-13
- Last updated
- 2021-11-03
- Other registries' IDs
- eudract:2015-004725-13
- Results first posted
- 2021-09-23
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (CMV Viremia Clearance) at End of Week 8 | Week 8 | Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration less than (\<) lower limit of quantification (LLOQ) that is, \<137 International Units per milliliter (IU/mL) when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive postbaseline samples, separated by at least 5 days. Percentage of participants with confirmed CMV viremia clearance at end of study Week 8 regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy, and could not have received alternative anti-CMV treatment were reported. |
| Secondary | Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at End of Week 8, Followed by Maintenance of Treatment Effect at Week 16 | Up to Week 16 | Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \<LLOQ that is, \<137 IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. CMV infection symptom control was defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline, or maintaining no symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline. Percentage of participants who achieved CMV viremia clearance and CMV infection symptom control at end of Week 8 through Week 16 were reported. |
| Secondary | Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment | At Week 8 through Weeks 12, 16 and 20 | Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \<LLOQ that is, \<137IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. Percentage of participants who achieved confirmed CMV viremia clearance after receiving 8 weeks study-assigned treatment at end of Week 8, and maintained this effect through 12, 16 and 20 were reported. |
| Secondary | Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20 | At Week 8 through Weeks 12, 16 and 20 | Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \<LLOQ that is, \<137IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. CMV infection symptom control was defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline, or maintaining no symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline. Percentage of participants who achieved confirmed CMV viremia clearance and CMV infection control after receiving 8 weeks study-assigned treatment at end of Week 8, and maintained this effect through 12, 16 and 20 were reported. |
| Secondary | Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at the End of Study Week 8 Through Weeks 12 and 20 Regardless of Whether Either Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy | At Week 8 through Weeks 12 and 20 | Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \<LLOQ that is, \<137IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. CMV infection symptom control was defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline or maintaining no symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline. Percentage of participants who maintained CMV viremia clearance and CMV infection symptom control at the end of study Week 8 through Weeks 12 and 20 regardless of whether either study-assigned treatment was discontinued before 8 weeks of therapy were reported. |
| Secondary | Percentage of Participants With Recurrence of CMV Viremia During the First 8 Weeks of Study Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy | At Week 8 | Recurrence of CMV viremia was 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 achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants with recurrence of CMV viremia during the first 8 weeks of study regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported. |
| Secondary | Percentage of Participants With Recurrence of CMV Viremia During the 12 Weeks Follow-up Period Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy | End of Week 8 up to Week 20 (12 weeks follow-up period) | Recurrence of CMV viremia was defined as plasma CMV DNA concentration \>=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants with recurrence of CMV viremia during the 12 weeks follow-up period regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported. |
| Secondary | Percentage of Participants With Recurrence of CMV Viremia at Any Time on Study Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy | Baseline up to Week 20 | Recurrence of CMV viremia was defined as plasma CMV DNA concentration \>=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants with recurrence of CMV viremia during at any time on study regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported. |
| Secondary | Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the First 8 Weeks of the Treatment | Baseline up to Week 8 | Recurrence of CMV viremia was defined as plasma CMV DNA concentration \>=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with recurrence of CMV viremia during the first 8 Weeks of the treatment who completed 8 weeks of study-assigned treatment were reported. |
| Secondary | Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 12 Weeks of Follow-up Period | End of Week 8 up to Week 20 (12 weeks follow-up period) | Recurrence of CMV viremia was defined as plasma CMV DNA concentration \>=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants who completed 8 weeks of study-assigned treatment with recurrence of CMV viremia during the 12 weeks of follow-up period were reported. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (CMV Viremia Clearance) at End of Week 8 | Week 8 | The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at End of Week 8, Followed by Maintenance of Treatment Effect at Week 16 | Up to Week 16 | The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment | At Week 8 through Weeks 12, 16 and 20 | The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20 | At Week 8 through Weeks 12, 16 and 20 | The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at the End of Study Week 8 Through Weeks 12 and 20 Regardless of Whether Either Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy | At Week 8 through Weeks 12 and 20 | The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Recurrence of CMV Viremia During the First 8 Weeks of Study Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy | At Week 8 | The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Recurrence of CMV Viremia During the 12 Weeks Follow-up Period Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy | End of Week 8 up to Week 20 (12 weeks follow-up period) | The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Recurrence of CMV Viremia at Any Time on Study Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy | Baseline up to Week 20 | The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the First 8 Weeks of the Treatment | Baseline up to Week 8 | The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study. Here overall number of participants analyzed were participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 12 Weeks of Follow-up Period | End of Week 8 up to Week 20 (12 weeks follow-up period) | The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study. Here overall number of participants analyzed were participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (CMV Viremia Clearance) at End of Week 8 | Investigator-assigned Anti-CMV Treatment (IAT) | 23.9 | percentage of participants | ||
| Percentage of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (CMV Viremia Clearance) at End of Week 8 | Maribavir 400 mg | 55.7 | percentage of participants | ||
| Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at End of Week 8, Followed by Maintenance of Treatment Effect at Week 16 | Investigator-assigned Anti-CMV Treatment (IAT) | 10.3 | percentage of participants | ||
| Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at End of Week 8, Followed by Maintenance of Treatment Effect at Week 16 | Maribavir 400 mg | 18.7 | percentage of participants | ||
| Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment | Investigator-assigned Anti-CMV Treatment (IAT) | At Week 8 | 18.8 | percentage of participants | |
| Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment | Maribavir 400 mg | At Week 8 | 54.9 | percentage of participants | |
| Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment | Investigator-assigned Anti-CMV Treatment (IAT) | At Week 12 | 5.1 | percentage of participants | |
| Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment | Maribavir 400 mg | At Week 12 | 22.6 | percentage of participants | |
| Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment | Investigator-assigned Anti-CMV Treatment (IAT) | At Week 16 | 5.1 | percentage of participants | |
| Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment | Maribavir 400 mg | At Week 16 | 18.7 | percentage of participants |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: Treatment Phase | STARTED | Investigator-assigned Anti-CMV Treatment (IAT) | 117 | |
| Period 1: Treatment Phase | STARTED | Maribavir 400 mg | 235 | |
| Period 1: Treatment Phase | STARTED | Maribavir Rescue Arm | 0 | |
| Period 1: Treatment Phase | Treated Participants | Investigator-assigned Anti-CMV Treatment (IAT) | 116 | |
| Period 1: Treatment Phase | Treated Participants | Maribavir 400 mg | 234 | |
| Period 1: Treatment Phase | Treated Participants | Maribavir Rescue Arm | 0 | |
| Period 1: Treatment Phase | IAT (Ganciclovir/ Valganciclovir) | Investigator-assigned Anti-CMV Treatment (IAT) | 56 | |
| Period 1: Treatment Phase | IAT (Ganciclovir/ Valganciclovir) | Maribavir 400 mg | 0 | |
| Period 1: Treatment Phase | IAT (Ganciclovir/ Valganciclovir) | Maribavir Rescue Arm | 0 | |
| Period 1: Treatment Phase | IAT (Foscarnet) | Investigator-assigned Anti-CMV Treatment (IAT) | 47 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events1,848
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 | IAT: Ganciclovir/ Valganciclovir | 7 | 56 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | IAT: Foscarnet | 10 | 47 | 12 |
| other | Anaemia | Blood and lymphatic system disorders | IAT: Cidofovir | 1 | 6 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | IAT: Foscarnet + Ganciclovir/ Valganciclovir | 1 | 7 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Maribavir 400 mg | 31 | 234 | 36 |
| other | Anaemia | Blood and lymphatic system disorders | Maribavir Rescue Arm | 3 | 22 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | IAT: Ganciclovir/ Valganciclovir | 7 | 56 | 8 |
| other | Leukopenia | Blood and lymphatic system disorders | IAT: Foscarnet | 2 | 47 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | IAT: Cidofovir | 0 | 6 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | IAT: Foscarnet + Ganciclovir/ Valganciclovir | 1 | 7 | 1 |
1 to 10 of 1,848Source ClinicalTrials.gov
See all 1,848 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IAT: Ganciclovir/ Valganciclovir | 6 | 56 |
| Total, all-cause mortality | IAT: Foscarnet | 7 | 47 |
| Total, all-cause mortality | IAT: Cidofovir | 0 | 6 |
| Total, all-cause mortality | IAT: Foscarnet + Ganciclovir/ Valganciclovir | 0 | 7 |
| Total, all-cause mortality | Maribavir 400 mg | 27 | 234 |
| Total, all-cause mortality | Maribavir Rescue Arm | 0 | 22 |
| Total, other adverse events | IAT: Ganciclovir/ Valganciclovir | 54 | 56 |
| Total, other adverse events | IAT: Foscarnet | 43 | 47 |
| Total, other adverse events | IAT: Cidofovir | 5 | 6 |
| Total, other adverse events | IAT: Foscarnet + Ganciclovir/ Valganciclovir | 7 | 7 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers7
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Investigator-assigned Anti-CMV Treatment (IAT) vs Maribavir 400 mg: Number of Participants With All-cause Mortality by the End of the Study |
Source 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/NCT02931539
GET https://conductscience.org/api/trials/v1/NCT02931539/registered?page=2