Trial · NCT01611974
Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients
NCT01611974, Phase 2, Completed, Shire; results first posted 2015-12-17
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients. Trials, record NCT01611974. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01611974
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients
- NCT number
- NCT01611974
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 120 participants, actual
- Lead sponsor
- Shire
- Conditions
- Cytomegalovirus (CMV)
- Interventions
- Maribavir
- First posted
- 2012-06-05
- Last updated
- 2021-06-02
- Results first posted
- 2015-12-17
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Within 6 Weeks | 6 weeks | Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. This method was linear over 200-100,000 viral copies/mL with a lower limit of quantification (LLOQ) of 200 copies/mL. Results below LLOQ were considered undetectable. Confirmed undetectable plasma CMV DNA within 6 weeks was defined as 2 consecutive post-baseline, on-treatment undetectable results separated by \>/= 5 days (assessed by the central laboratory). Samples were collected on Days 1 and 8, weekly during Weeks 2-6, and once in Weeks 8, 10, 12, 16, 20, 24 (treatment) and Weeks 1, 4, 8, 12 (follow-up). Permissible assessment windows were: Days 8-15 +/- 1 day; Weeks 3-4 +/- 2 days; Weeks 5-6 +/- 3 days; Weeks 8-12 +/- 4 days; Weeks 16-24 +/- 7 days (treatment) and Weeks 1-4 +/- 2 days; Weeks 8-12 +/- 4 days (follow-up). |
| Primary | Number of Participants With a Treatment Emergent Adverse Event (TEAE). | 25 weeks | Treatment-emergent adverse events are those events that occurred on or after study drug administration through 7 days after the last dose of study drug, or are events that occurred prior to study drug administration and recurred with increased severity after taking study drug through 7 days after the last dose of study drug. |
| Secondary | Number of Participants With CMV Recurrence | 36 weeks | Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. CMV recurrence was defined as achievement of undetectable plasma CMV DNA at any time after Day 1 in at least 2 consecutive samples separated by at least 5 days, followed by detectable plasma CMV DNA in at least 2 consecutive samples separated by at least 5 days (assessed by the central laboratory). For the analyses of CMV recurrence, the first of 2 consecutive confirmed undetectable plasma CMV DNA results had to be on-treatment. CMV DNA PCR values of ≥200 copies/mL were considered detectable. Participants assessed for recurrence (n= 29, 27, 30) are the subset of the ITT-S who had at least 2 consecutive undetectable plasma CMV DNA results separated by at least 5 days, including early withdrawn qualified subjects. |
| Secondary | Time to First Confirmed Undetectable Plasma CMV DNA Within 6 Weeks and at Any Time During The Study | 6 weeks after start of treatment, within 36 weeks of start of treatment | Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. The time to event was defined as the time from first dose of study drug to first undetectable plasma CMV DNA within 6 weeks and at any time during the study, defined as the date of the first of at least 2 consecutive post-baseline, on-treatment undetectable results (\<200 copies/mL) separated by at least 5 days; as assessed by the central laboratory. The median values are Kaplan-Meier estimates. |
| Secondary | Time to CMV Recurrence | 36 weeks | Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. The time to event was defined as the time of the first of at least 2 consecutive samples, separated by at least 5 days, with detectable plasma CMV DNA after achievement of undetectable plasma CMV DNA in at least 2 consecutive samples, separated by at least 5 days, at any time after Day 1; as assessed by the central laboratory. Participants assessed for recurrence (n= 29, 27, 30) are the subset of the ITT-S who had at least 2 consecutive undetectable plasma CMV DNA results separated by at least 5 days, including early withdrawn qualified subjects. The median values are Kaplan-Meier estimates. |
| Secondary | Maximum Concentration (Cmax) of Maribavir | pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit | For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days. |
| Secondary | Time to Maximum Concentration (Tmax) of Maribavir | pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit | For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days. |
| Secondary | Time of Last Non-Zero Concentration (Tlast) of Maribavir | pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit | For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days. |
| Secondary | Area Under The Plasma Concentration Versus Time Curve From The Time of Dosing to The Last Measurable Concentration (AUClast) of Maribavir | pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit | For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days. |
| Secondary | Half-Life (T½) of Maribavir | pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit | For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days. |
Source ClinicalTrials.gov
Outcomes10
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 Confirmed Undetectable Plasma Cytomegalovirus (CMV) Within 6 Weeks | 6 weeks | The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug. | participants | NUMBER |
| PRIMARY | Number of Participants With a Treatment Emergent Adverse Event (TEAE). | 25 weeks | The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With CMV Recurrence | 36 weeks | The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug. | participants | NUMBER |
| SECONDARY | Time to First Confirmed Undetectable Plasma CMV DNA Within 6 Weeks and at Any Time During The Study | 6 weeks after start of treatment, within 36 weeks of start of treatment | The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug. | days | MEDIAN |
| SECONDARY | Time to CMV Recurrence | 36 weeks | The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug. | days | MEDIAN |
| SECONDARY | Maximum Concentration (Cmax) of Maribavir | pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit | The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations | ug/mL | MEAN |
| SECONDARY | Time to Maximum Concentration (Tmax) of Maribavir | pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit | The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations. | hours | MEAN |
| SECONDARY | Time of Last Non-Zero Concentration (Tlast) of Maribavir | pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit | The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations. | hours | MEAN |
| SECONDARY | Area Under The Plasma Concentration Versus Time Curve From The Time of Dosing to The Last Measurable Concentration (AUClast) of Maribavir | pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit | The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations. | h*ug/mL | MEAN |
| SECONDARY | Half-Life (T½) of Maribavir | pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit | The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations. | hours | MEAN |
Source ClinicalTrials.gov
Results by group51
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 Confirmed Undetectable Plasma Cytomegalovirus (CMV) Within 6 Weeks | Maribavir 400 mg Twice Daily | 28 | participants | ||
| Number of Participants With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Within 6 Weeks | Maribavir 800 mg Twice Daily | 25 | participants | ||
| Number of Participants With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Within 6 Weeks | Maribavir 1200 mg Twice Daily | 27 | participants | ||
| Number of Participants With a Treatment Emergent Adverse Event (TEAE). | Maribavir 400 mg Twice Daily | Any TEAE | 40 | participants | |
| Number of Participants With a Treatment Emergent Adverse Event (TEAE). | Maribavir 800 mg Twice Daily | Any TEAE | 40 | participants | |
| Number of Participants With a Treatment Emergent Adverse Event (TEAE). | Maribavir 1200 mg Twice Daily | Any TEAE | 40 | participants | |
| Number of Participants With a Treatment Emergent Adverse Event (TEAE). | Maribavir 400 mg Twice Daily | Serious TEAE | 28 | participants | |
| Number of Participants With a Treatment Emergent Adverse Event (TEAE). | Maribavir 800 mg Twice Daily | Serious TEAE | 27 | participants | |
| Number of Participants With a Treatment Emergent Adverse Event (TEAE). | Maribavir 1200 mg Twice Daily | Serious TEAE | 26 | participants | |
| Number of Participants With CMV Recurrence | Maribavir 400 mg Twice Daily | 7 | participants |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Maribavir 400 mg Twice Daily | 40 | |
| Overall Study | STARTED | Maribavir 800 mg Twice Daily | 40 | |
| Overall Study | STARTED | Maribavir 1200 mg Twice Daily | 40 | |
| Overall Study | COMPLETED | Maribavir 400 mg Twice Daily | 25 | |
| Overall Study | COMPLETED | Maribavir 800 mg Twice Daily | 25 | |
| Overall Study | COMPLETED | Maribavir 1200 mg Twice Daily | 24 | |
| Overall Study | NOT COMPLETED | Maribavir 400 mg Twice Daily | 15 | |
| Overall Study | NOT COMPLETED | Maribavir 800 mg Twice Daily | 15 | |
| Overall Study | NOT COMPLETED | Maribavir 1200 mg Twice Daily | 16 |
Source ClinicalTrials.gov
Adverse events600
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 | Dysgeusia | Nervous system disorders | Maribavir 400 mg Twice Daily | 24 | 40 | |
| other | Dysgeusia | Nervous system disorders | Maribavir 800 mg Twice Daily | 25 | 40 | |
| other | Dysgeusia | Nervous system disorders | Maribavir 1200 mg Twice Daily | 29 | 40 | |
| other | Nausea | Gastrointestinal disorders | Maribavir 400 mg Twice Daily | 14 | 40 | |
| other | Nausea | Gastrointestinal disorders | Maribavir 800 mg Twice Daily | 9 | 40 | |
| other | Nausea | Gastrointestinal disorders | Maribavir 1200 mg Twice Daily | 12 | 40 | |
| other | Vomiting | Gastrointestinal disorders | Maribavir 400 mg Twice Daily | 11 | 40 | |
| other | Vomiting | Gastrointestinal disorders | Maribavir 800 mg Twice Daily | 12 | 40 | |
| other | Vomiting | Gastrointestinal disorders | Maribavir 1200 mg Twice Daily | 11 | 40 | |
| other | Cytomegalovirus infection | Infections and infestations | Maribavir 400 mg Twice Daily | 3 | 40 |
1 to 10 of 600Source ClinicalTrials.gov
See all 600 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Maribavir 400 mg Twice Daily | ||
| Total, all-cause mortality | Maribavir 800 mg Twice Daily | ||
| Total, all-cause mortality | Maribavir 1200 mg Twice Daily | ||
| Total, other adverse events | Maribavir 400 mg Twice Daily | 40 | 40 |
| Total, other adverse events | Maribavir 800 mg Twice Daily | 40 | 40 |
| Total, other adverse events | Maribavir 1200 mg Twice Daily | 40 | 40 |
| Total, serious adverse events | Maribavir 400 mg Twice Daily | 28 | 40 |
| Total, serious adverse events | Maribavir 800 mg Twice Daily | 27 | 40 |
| Total, serious adverse events | Maribavir 1200 mg Twice Daily | 26 | 40 |
Source ClinicalTrials.gov
Papers5
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01611974
GET https://conductscience.org/api/trials/v1/NCT01611974/results?page=2