Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00497796
First received: July 5, 2007
Last updated: July 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Cytomegalovirus Infections
Drug: maribavir
Drug: ganciclovir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • CMV disease [ Time Frame: 6 months post transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CMV disease [ Time Frame: 100 days and 12 months post-transplant ] [ Designated as safety issue: No ]
  • Incidence of CMV infection [ Time Frame: 100 days and 12 months post-transplant ] [ Designated as safety issue: No ]
  • Incidence of graft rejection [ Time Frame: 100 days and 12 months post-transplant ] [ Designated as safety issue: No ]
  • Incidence of retransplantation [ Time Frame: 100 days and 12 months post-transplant ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 100 days and 12 months post-transplant ] [ Designated as safety issue: No ]

Estimated Enrollment: 348
Study Start Date: July 2007
Study Completion Date: September 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: maribavir
100mg twice a day for 14 weeks.
Active Comparator: 2 Drug: ganciclovir
1000mg three times per day for 14 weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Orthotopic liver transplant recipient
  • Donor CMV seropositive / Recipient CMV seronegative
  • Enrolled within 10 days after liver transplant
  • Able to swallow tablets

Exclusion Criteria:

  • Multiple organ transplant
  • HIV infection
  • CMV disease
  • Use of other anti-CMV therapy at time of enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497796

  Show 55 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Stephen A Villano, MD ViroPharma
  More Information

No publications provided

Responsible Party: Stephen Villano, MD, Viropharma, Inc.
ClinicalTrials.gov Identifier: NCT00497796     History of Changes
Other Study ID Numbers: 1263-301, 2007-004729-16
Study First Received: July 5, 2007
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
cytomegalovirus
CMV
prophylaxis
liver
liver transplant

Additional relevant MeSH terms:
Cytomegalovirus Infections
DNA Virus Infections
Herpesviridae Infections
Virus Diseases
Ganciclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014