NCT00223925

Maribavir for Prevention of CMV After Stem Cell Transplants

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00223925

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, and Prophylactic Anti-cytomegalovirus Activity of Maribavir in Recipients of Allogeneic Stem Cell Transplants

Summary

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 anti-CMV activity of different doses of maribavir when given as CMV prophylaxis following stem cell transplants.

Eligibility

Inclusion Criteria:

* Allogeneic stem cell transplant recipient
* Recipient CMV seropositive
* Have transplant engraftment
* Able to swallow tablets

Exclusion Criteria:

* CMV organ disease
* HIV infection
* Use of other anti-CMV therapy post-transplant

Disease(s) and\or Condition(s)

Cytomegalovirus Infection

Primary Purpose

PREVENTION

Intervention/Treatment

- Type: DRUG
- Name: Maribavir
- Description:
- Arm Group Labels: Maribavir (100 mg twice daily), Maribavir (400 mg once daily), Maribavir (400 mg twice daily)
- Type: DRUG
- Name: Placebo
- Description:
- Arm Group Labels: Placebo

Sponsor

Shire