Trials / Completed
CompletedNCT02931539
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
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety 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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 352 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the efficacy of maribavir to investigator-assigned anti-Cytomegalovirus (CMV) therapy in CMV viremia clearance in transplant recipients who are refractory or resistant to prior anti-CMV treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Maribavir | Maribavir 400 milligrams (mg) (2x200 mg tablets) will be administered twice daily for 8 weeks. |
| DRUG | Ganciclovir | Ganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks. |
| DRUG | Valganciclovir | Valganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks. |
| DRUG | Foscarnet | Foscarnet as per the investigator's prescribed dosing regimen will be administered for 8 weeks. |
| DRUG | Cidofovir | Cidofovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks. |
Timeline
- Start date
- 2016-12-22
- Primary completion
- 2020-08-17
- Completion
- 2020-08-17
- First posted
- 2016-10-13
- Last updated
- 2021-11-03
- Results posted
- 2021-09-23
Locations
134 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Italy, Singapore, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02931539. Inclusion in this directory is not an endorsement.