MedTrace Logo

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

NCT02931539 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2021-11-03

Study results available
· View outcomes & findings →

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

  • Cytomegalovirus (CMV)

Interventions

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.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Shire

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-22
Primary Completion
2020-08-17
Completion
2020-08-17
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Croatia
  • Denmark
  • France
  • Germany
  • Italy
  • Singapore
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02931539 on ClinicalTrials.gov