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

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ClinicalTrials.gov Identifier: NCT00497796
Recruitment Status : Completed
First Posted : July 9, 2007
Results First Posted : June 4, 2015
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition: Cytomegalovirus Infections
Interventions: Drug: maribavir
Drug: ganciclovir

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Maribavir 100 mg BID Maribavir: 100mg twice a day (BID) for 14 weeks.
Ganciclovir 1000 mg TID Ganciclovir: 1000mg three times per (TID) day for 14 weeks.

Participant Flow:   Overall Study
    Maribavir 100 mg BID   Ganciclovir 1000 mg TID
STARTED   147   160 
COMPLETED   62   101 
NOT COMPLETED   85   59 
Adverse event (not related)                9                9 
Adverse event (related)                5                4 
CMV infection or disease treatment                30                4 
Consent withdrawn                10                3 
Investigator/sponsor discretion                31                34 
Lost to Follow-up                0                1 
Not applicable (randomized not treated)                0                4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat Safety (ITT-S) population, defined as all randomized subjects who received at least one dose of study drug, regardless of whether they had any post-baseline evaluations.

Reporting Groups
  Description
Maribavir 100 mg BID Maribavir: 100mg twice a day (BID) for 14 weeks.
Ganciclovir 1000 mg TID Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
Total Total of all reporting groups

Baseline Measures
   Maribavir 100 mg BID   Ganciclovir 1000 mg TID   Total 
Overall Participants Analyzed 
[Units: Participants]
 147   156   303 
Age 
[Units: Years]
Mean (Standard Deviation)
 55  (9.0)   53  (8.9)   54  (9.0) 
Gender 
[Units: Participants]
     
Female   27   37   64 
Male   120   119   239 
Distribution of age 
[Units: Participants]
     
18 to 44 years   19   22   41 
45 to 64 years   109   123   232 
65 to 75 years   19   11   30 


  Outcome Measures

1.  Primary:   Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation   [ Time Frame: 6 months post-transplant ]

2.  Secondary:   Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation   [ Time Frame: 6 months post-transplant ]

3.  Secondary:   Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation   [ Time Frame: 6 months post-transplant ]

4.  Secondary:   Number of Participants With Investigator-determined CMV Disease   [ Time Frame: Through 6 months post-transplant (Day 1 to 100 days and 6 months post-transplant) ]

5.  Secondary:   Number of Participants With EC-confirmed CMV Disease Within 100 Days Post-Transplantation   [ Time Frame: 100 days post-transplant ]

6.  Secondary:   Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation   [ Time Frame: 100 days post-transplant ]

7.  Secondary:   Number of Participants With Retransplantation   [ Time Frame: Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant) ]

8.  Secondary:   Number of Participants With Graft Failure Related Death   [ Time Frame: Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant) ]

9.  Secondary:   Number of Participants With Acute Graft Rejection   [ Time Frame: 26 weeks post-transplant ]

10.  Secondary:   Number of Participants Who Died Within 6 Months Post-Transplantation   [ Time Frame: 6 months post-transplant ]

11.  Secondary:   Percent of Participants With Signs of Bone Marrow Suppression   [ Time Frame: 15 weeks ]

12.  Secondary:   Plasma Concentration of Maribavir During Treatment   [ Time Frame: 12 hours post-dose after 2, 6, and 10 weeks of treatment ]

13.  Secondary:   Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment   [ Time Frame: 12 hours post-dose after 2, 6, and 10 weeks of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Physician
Organization: Shire Development LLC
phone: +1 866 842 5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00497796     History of Changes
Other Study ID Numbers: 1263-301
2007-004729-16 ( EudraCT Number )
SHP620-301 ( Other Identifier: Shire )
First Submitted: July 5, 2007
First Posted: July 9, 2007
Results First Submitted: May 4, 2015
Results First Posted: June 4, 2015
Last Update Posted: June 4, 2015