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Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01611974
First received: June 1, 2012
Last updated: November 13, 2015
Last verified: December 2014
Results First Received: November 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Cytomegalovirus Infections
Intervention: Drug: Maribavir

  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
No text entered.

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
Maribavir 400 mg Twice Daily Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Maribavir 800 mg Twice Daily Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Maribavir 1200 mg Twice Daily Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.

Participant Flow:   Overall Study
    Maribavir 400 mg Twice Daily     Maribavir 800 mg Twice Daily     Maribavir 1200 mg Twice Daily  
STARTED     40     40     40  
COMPLETED     25     25     24  
NOT COMPLETED     15     15     16  
Death                 10                 12                 10  
Lost to Follow-up                 0                 1                 0  
Physician Decision                 5                 1                 2  
Withdrawal by Subject                 0                 1                 4  



  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.
The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Maribavir 400 mg Twice Daily Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Maribavir 800 mg Twice Daily Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Maribavir 1200 mg Twice Daily Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Maribavir 400 mg Twice Daily     Maribavir 800 mg Twice Daily     Maribavir 1200 mg Twice Daily     Total  
Number of Participants  
[units: participants]
  40     40     40     120  
Age  
[units: years]
Mean (Standard Deviation)
  52.1  (14.25)     55.4  (14.13)     50.0  (12.96)     52.5  (13.86)  
Age, Customized  
[units: participants]
       
18 to 44 years     11     10     14     35  
45 to 64 years     22     18     20     60  
65 to 75 years     7     12     6     25  
Gender  
[units: participants]
       
Female     19     16     16     51  
Male     21     24     24     69  



  Outcome Measures
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1.  Primary:   Number of Participants With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Within 6 Weeks   [ Time Frame: 6 weeks ]

2.  Primary:   Number of Participants With a Treatment Emergent Adverse Event (TEAE).   [ Time Frame: 25 weeks ]

3.  Secondary:   Number of Participants With CMV Recurrence   [ Time Frame: 36 weeks ]

4.  Secondary:   Time to First Confirmed Undetectable Plasma CMV DNA Within 6 Weeks and at Any Time During The Study   [ Time Frame: 6 weeks after start of treatment, within 36 weeks of start of treatment ]

5.  Secondary:   Time to CMV Recurrence   [ Time Frame: 36 weeks ]

6.  Secondary:   Maximum Concentration (Cmax) of Maribavir   [ Time Frame: pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit ]

7.  Secondary:   Time to Maximum Concentration (Tmax) of Maribavir   [ Time Frame: pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit ]

8.  Secondary:   Time of Last Non-Zero Concentration (Tlast) of Maribavir   [ Time Frame: pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit ]

9.  Secondary:   Area Under The Plasma Concentration Versus Time Curve From The Time of Dosing to The Last Measurable Concentration (AUClast) of Maribavir   [ Time Frame: pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit ]

10.  Secondary:   Half-Life (T½) of Maribavir   [ Time Frame: pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit ]


  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: NCT01611974     History of Changes
Other Study ID Numbers: 1263-202
SHP620-202 ( Other Identifier: Shire Development LLC )
Study First Received: June 1, 2012
Results First Received: November 13, 2015
Last Updated: November 13, 2015
Health Authority: United States: Food and Drug Administration