NCT00411645

Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT00411645

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus Disease in Recipients of Allogeneic Stem Cell Transplants.

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

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

Disease(s) and\or Condition(s)

Cytomegalovirus Infections

Primary Purpose

PREVENTION

Intervention/Treatment

- Type: DRUG
- Name: maribavir
- Description: 100 mg twice daily for up to 12 weeks
- Arm Group Labels: A
- Type: OTHER
- Name: placebo
- Description: twice daily for up to 12 weeks
- Arm Group Labels: B

Sponsor

Shire