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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00411645
First received: December 12, 2006
Last updated: June 3, 2015
Last verified: March 2014
Results First Received: May 15, 2015  
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
Condition: Cytomegalovirus Infections
Interventions: Drug: maribavir
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Participants received placebo twice daily (BID) for up to 12 weeks.
Maribavir 100 mg BID Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.

Participant Flow:   Overall Study
    Placebo   Maribavir 100 mg BID
STARTED   227   454 
COMPLETED   146   290 
NOT COMPLETED   81   164 
Consent Withdrawn                13                22 
Death                56                135 
Investigator/Sponsor Decision                10                7 
Lost to Follow-up                2                0 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Placebo Participants received placebo twice daily (BID) for up to 12 weeks.
Maribavir 100 mg BID Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Maribavir 100 mg BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 227   454   681 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (13.1)   49  (12.5)   49  (12.7) 
Age, Customized 
[Units: Participants]
     
18 to 44 years   74   136   210 
45 to 64 years   134   286   420 
65 to 75 years   18   32   50 
> 75 years   1   0   1 
Gender 
[Units: Participants]
     
Female   98   189   287 
Male   129   265   394 


  Outcome Measures
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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-transplant   [ 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 12 months post-transplant (Day 1 to 100 days, 6 months, and 12 months post-transplant) ]

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

6.  Secondary:   Number of Participants With EC-confirmed CMV Disease Within 12 Months Post-Transplantation   [ Time Frame: 12 months post-transplant ]

7.  Secondary:   Percent of Participants With Acute Graft-Versus-Host Disease (GVHD)   [ Time Frame: Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant) ]

8.  Secondary:   Percent of Participants With Chronic Graft-Versus-Host Disease (GVHD)   [ Time Frame: Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant) ]

9.  Secondary:   Number of Participants Who Died Within 12 Months Post-Transplantation   [ Time Frame: Through 12 months post-transplant (Days 1 to 100, 6 months, and 12 months post-transplant) ]

10.  Secondary:   Plasma Concentration of Maribavir During Treatment   [ Time Frame: 12 hours post-dose after 1 and 4 weeks of treatment ]

11.  Secondary:   Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment   [ Time Frame: 12 hours post-dose after 1 and 4 weeks of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00411645     History of Changes
Obsolete Identifiers: NCT00430339
Other Study ID Numbers: 1263-300
2006-005692-18 ( EudraCT Number )
SHP620-300 ( Other Identifier: Shire )
Study First Received: December 12, 2006
Results First Received: May 15, 2015
Last Updated: June 3, 2015
Health Authority: United States: Food and Drug Administration