Phase 3
N=681
Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients
Cytomegalovirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT00411645 ↗Enrolled (actual)
681
Serious AEs
43.8%
Results posted
Jun 2015
Primary outcome: Primary: Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation — 11; 20 participants — p=0.789
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- maribavir (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation |
11; 20 | 0.789 |
| SECONDARY Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-transplant |
88; 143; 77; 152; 101; 183 | 0.056 |
| SECONDARY Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post- Transplantation |
21; 22 | 0.129 |
| SECONDARY Number of Participants With Investigator-determined CMV Disease |
6; 16; 11; 26; 13; 28 | 0.542 |
| SECONDARY Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation |
79; 120; 69; 126; 92; 157 | 0.022 sig |
| SECONDARY Number of Participants With EC-confirmed CMV Disease Within 12 Months Post-Transplantation |
13; 22 | 0.617 |
| SECONDARY Percent of Participants With Acute Graft-Versus-Host Disease (GVHD) |
39; 40; 43; 44 | 0.7808 |
| SECONDARY Percent of Participants With Chronic Graft-Versus-Host Disease (GVHD) |
5; 6; 25; 19 | 0.6304 |
| SECONDARY Number of Participants Who Died Within 12 Months Post-Transplantation |
19; 30; 37; 88; 59; 139 | — |
| SECONDARY Plasma Concentration of Maribavir During Treatment |
2.11; 2.19 | — |
| SECONDARY Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment |
0.56; 0.65 | — |
Summary
The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.
Eligibility Criteria
Inclusion Criteria
- Allogeneic stem cell transplant recipient
- Recipient or donor CMV seropositive
- Have transplant engraftment
- Able to swallow tablets
Exclusion Criteria
- CMV organ disease
- HIV infection
- Use of other anti-CMV therapy post-transplant
Data sourced from ClinicalTrials.gov (NCT00411645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.