Trials / Completed
CompletedNCT00497796
Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients
A Randomized, Double-blind Study To Assess The Efficacy And Safety Of Prophylactic Use Of Maribavir Versus Oral Ganciclovir For The Prevention Of Cytomegalovirus Disease In Recipients Of Orthotopic Liver Transplants
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 307 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to investigate whether or not oral maribavir is safe and effective compared to oral ganciclovir for preventing CMV disease when administered for up to 14 weeks in patients who have had a liver transplant.
Detailed description
Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and efficacy of maribavir for the prevention of CMV disease when given as prophylaxis for up to 14 weeks following orthotopic liver transplantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | maribavir | 100mg twice a day for 14 weeks. |
| DRUG | ganciclovir | 1000mg three times per day for 14 weeks. |
Timeline
- Start date
- 2007-07-23
- Primary completion
- 2009-09-14
- Completion
- 2009-09-14
- First posted
- 2007-07-09
- Last updated
- 2021-06-11
- Results posted
- 2015-06-04
Locations
55 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00497796. Inclusion in this directory is not an endorsement.