Phase 3 N=307 Randomized Triple-blind Prevention

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

Cytomegalovirus Infections

Bottom Line

View on ClinicalTrials.gov: NCT00497796 ↗

Enrolled (actual)

307

Serious AEs

48.5%

Results posted

Jun 2015

Primary outcome: Primary: Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation — 14; 10 number of participants with event — p=0.2754

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: maribavir (Drug); ganciclovir (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Shire
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation	14; 10	0.2754
SECONDARY Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation	63; 49; 72; 52; 81; 64	0.0283 sig
SECONDARY Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation	45; 127	<0.0001 sig
SECONDARY Number of Participants With Investigator-determined CMV Disease	17; 3; 22; 18	0.0008 sig
SECONDARY Number of Participants With EC-confirmed CMV Disease Within 100 Days Post-Transplantation	10; 0	0.0007 sig
SECONDARY Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation	49; 19; 59; 18; 68; 24	<0.0001 sig
SECONDARY Number of Participants With Retransplantation	1; 2; 2; 2	—
SECONDARY Number of Participants With Graft Failure Related Death	0; 2; 1; 2	—
SECONDARY Number of Participants With Acute Graft Rejection	16; 19; 20; 23	—
SECONDARY Number of Participants Who Died Within 6 Months Post-Transplantation	9; 6	—
SECONDARY Percent of Participants With Signs of Bone Marrow Suppression	14; 21; 9; 16; 16; 21	—
SECONDARY Plasma Concentration of Maribavir During Treatment	1.65; 1.36; 1.55	—
SECONDARY Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment	0.609; 0.506; 0.666	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00497796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.