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Trial record 11 of 304 for:    "Cytomegalic inclusion disease"

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

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ClinicalTrials.gov Identifier: NCT01611974
Recruitment Status : Completed
First Posted : June 5, 2012
Results First Posted : December 17, 2015
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cytomegalovirus Infections
Intervention Drug: Maribavir
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily
Hide Arm/Group Description Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks. Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks. Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Period Title: Overall Study
Started 40 40 40
Completed 25 25 24
Not Completed 15 15 16
Reason Not Completed
Death             10             12             10
Lost to Follow-up             0             1             0
Physician Decision             5             1             2
Withdrawal by Subject             0             1             4
Arm/Group Title Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily Total
Hide Arm/Group Description Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks. Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks. Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 40 40 40 120
Hide Baseline Analysis Population Description
The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 40 participants 120 participants
52.1  (14.25) 55.4  (14.13) 50.0  (12.96) 52.5  (13.86)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 120 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
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 120 participants
Female
19
  47.5%
16
  40.0%
16
  40.0%
51
  42.5%
Male
21
  52.5%
24
  60.0%
24
  60.0%
69
  57.5%
1.Primary Outcome
Title Number of Participants With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Within 6 Weeks
Hide Description Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. This method was linear over 200-100,000 viral copies/mL with a lower limit of quantification (LLOQ) of 200 copies/mL. Results below LLOQ were considered undetectable. Confirmed undetectable plasma CMV DNA within 6 weeks was defined as 2 consecutive post-baseline, on-treatment undetectable results separated by >/= 5 days (assessed by the central laboratory). Samples were collected on Days 1 and 8, weekly during Weeks 2-6, and once in Weeks 8, 10, 12, 16, 20, 24 (treatment) and Weeks 1, 4, 8, 12 (follow-up). Permissible assessment windows were: Days 8-15 +/- 1 day; Weeks 3-4 +/- 2 days; Weeks 5-6 +/- 3 days; Weeks 8-12 +/- 4 days; Weeks 16-24 +/- 7 days (treatment) and Weeks 1-4 +/- 2 days; Weeks 8-12 +/- 4 days (follow-up).
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily
Hide Arm/Group Description:
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Overall Number of Participants Analyzed 40 40 38
Measure Type: Number
Unit of Measure: participants
28 25 27
2.Primary Outcome
Title Number of Participants With a Treatment Emergent Adverse Event (TEAE).
Hide Description Treatment-emergent adverse events are those events that occurred on or after study drug administration through 7 days after the last dose of study drug, or are events that occurred prior to study drug administration and recurred with increased severity after taking study drug through 7 days after the last dose of study drug.
Time Frame 25 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily
Hide Arm/Group Description:
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Overall Number of Participants Analyzed 40 40 40
Measure Type: Number
Unit of Measure: participants
Any TEAE 40 40 40
Serious TEAE 28 27 26
3.Secondary Outcome
Title Number of Participants With CMV Recurrence
Hide Description Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. CMV recurrence was defined as achievement of undetectable plasma CMV DNA at any time after Day 1 in at least 2 consecutive samples separated by at least 5 days, followed by detectable plasma CMV DNA in at least 2 consecutive samples separated by at least 5 days (assessed by the central laboratory). For the analyses of CMV recurrence, the first of 2 consecutive confirmed undetectable plasma CMV DNA results had to be on-treatment. CMV DNA PCR values of ≥200 copies/mL were considered detectable. Participants assessed for recurrence (n= 29, 27, 30) are the subset of the ITT-S who had at least 2 consecutive undetectable plasma CMV DNA results separated by at least 5 days, including early withdrawn qualified subjects.
Time Frame 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily
Hide Arm/Group Description:
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Overall Number of Participants Analyzed 40 40 40
Measure Type: Number
Unit of Measure: participants
7 11 12
4.Secondary Outcome
Title Time to First Confirmed Undetectable Plasma CMV DNA Within 6 Weeks and at Any Time During The Study
Hide Description Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. The time to event was defined as the time from first dose of study drug to first undetectable plasma CMV DNA within 6 weeks and at any time during the study, defined as the date of the first of at least 2 consecutive post-baseline, on-treatment undetectable results (<200 copies/mL) separated by at least 5 days; as assessed by the central laboratory. The median values are Kaplan-Meier estimates.
Time Frame 6 weeks after start of treatment, within 36 weeks of start of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily
Hide Arm/Group Description:
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Overall Number of Participants Analyzed 40 40 40
Median (95% Confidence Interval)
Unit of Measure: days
Within 6 weeks, n = 40, 40, 38
24.0
(15.0 to 31.0)
28.0
(15.0 to 36.0)
22.0
(15.0 to 28.0)
Anytime during the study, n = 40, 40, 40
24.0
(15.0 to 31.0)
28.0
(15.0 to 38.0)
22.0
(19.0 to 30.0)
5.Secondary Outcome
Title Time to CMV Recurrence
Hide Description Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. The time to event was defined as the time of the first of at least 2 consecutive samples, separated by at least 5 days, with detectable plasma CMV DNA after achievement of undetectable plasma CMV DNA in at least 2 consecutive samples, separated by at least 5 days, at any time after Day 1; as assessed by the central laboratory. Participants assessed for recurrence (n= 29, 27, 30) are the subset of the ITT-S who had at least 2 consecutive undetectable plasma CMV DNA results separated by at least 5 days, including early withdrawn qualified subjects. The median values are Kaplan-Meier estimates.
Time Frame 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily
Hide Arm/Group Description:
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Overall Number of Participants Analyzed 40 40 40
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
118.0 [2] 
(37.0 to NA)
161.0 [2] 
(92.0 to NA)
[1]
The median and 95% CIs were not estimable.
[2]
The upper 95% CI was not estimable.
6.Secondary Outcome
Title Maximum Concentration (Cmax) of Maribavir
Hide Description For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.
Time Frame pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations
Arm/Group Title Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily
Hide Arm/Group Description:
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Overall Number of Participants Analyzed 12 13 8
Mean (Standard Deviation)
Unit of Measure: ug/mL
Visit 3, n = 12, 10, 8 18.5  (7.39) 35.1  (12.0) 45.1  (21.2)
Visit 6, n = 8, 10, 6 17.8  (8.36) 25.0  (9.69) 35.6  (25.8)
7.Secondary Outcome
Title Time to Maximum Concentration (Tmax) of Maribavir
Hide Description For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.
Time Frame pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.
Arm/Group Title Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily
Hide Arm/Group Description:
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Overall Number of Participants Analyzed 12 13 8
Mean (Standard Deviation)
Unit of Measure: hours
Visit 3, n = 12, 10, 8 3.56  (2.99) 2.70  (2.89) 2.81  (2.02)
Visit 6, n = 8, 10, 6 1.66  (0.765) 3.23  (2.28) 3.12  (1.05)
8.Secondary Outcome
Title Time of Last Non-Zero Concentration (Tlast) of Maribavir
Hide Description For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.
Time Frame pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.
Arm/Group Title Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily
Hide Arm/Group Description:
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Overall Number of Participants Analyzed 12 13 8
Mean (Standard Deviation)
Unit of Measure: hours
Visit 3, n = 12, 10, 8 9.03  (2.55) 8.26  (2.48) 8.71  (1.45)
Visit 6, n = 8, 10, 6 7.37  (3.70) 7.99  (1.65) 8.61  (1.64)
9.Secondary Outcome
Title Area Under The Plasma Concentration Versus Time Curve From The Time of Dosing to The Last Measurable Concentration (AUClast) of Maribavir
Hide Description For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.
Time Frame pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.
Arm/Group Title Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily
Hide Arm/Group Description:
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Overall Number of Participants Analyzed 12 13 8
Mean (Standard Deviation)
Unit of Measure: h*ug/mL
Visit 3, n = 12, 10, 8 100  (50.4) 179  (69.6) 264  (147)
Visit 6, n = 8, 10, 6 90.9  (64.3) 139  (61.3) 207  (161)
10.Secondary Outcome
Title Half-Life (T½) of Maribavir
Hide Description For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.
Time Frame pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.
Arm/Group Title Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily
Hide Arm/Group Description:
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
Overall Number of Participants Analyzed 12 13 8
Mean (Standard Deviation)
Unit of Measure: hours
Visit 3, n = 6, 7, 3 5.56  (3.85) 6.08  (3.51) 7.77  (3.59)
Visit 6, n = 5, 5, 3 4.32  (1.25) 6.34  (1.41) 5.33  (2.55)
Time Frame [Not Specified]
Adverse Event Reporting Description Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
 
Arm/Group Title Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily
Hide Arm/Group Description Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks. Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks. Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
All-Cause Mortality
Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/40 (70.00%)   27/40 (67.50%)   26/40 (65.00%) 
Blood and lymphatic system disorders       
Anaemia   4/40 (10.00%)  0/40 (0.00%)  0/40 (0.00%) 
Haemolysis   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Pancytopenia   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Cardiac disorders       
Cardiac tamponade   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Pericardial effusion   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Cardiac failure congestive   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Eye disorders       
Vision blurred   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Gastrointestinal disorders       
Abdominal pain   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Ascites   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Haematemesis   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Small intestinal obstruction   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Diarrhoea   0/40 (0.00%)  2/40 (5.00%)  1/40 (2.50%) 
Gastrointestinal haemorrhage   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Ileus   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Nausea   1/40 (2.50%)  3/40 (7.50%)  3/40 (7.50%) 
Pancreatitis   0/40 (0.00%)  1/40 (2.50%)  1/40 (2.50%) 
Vomiting   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Jejunal ulcer   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
General disorders       
Fatigue   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Multi-organ failure   1/40 (2.50%)  1/40 (2.50%)  2/40 (5.00%) 
Pyrexia   2/40 (5.00%)  1/40 (2.50%)  0/40 (0.00%) 
Asthenia   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Generalised oedema   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Oedema peripheral   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Hepatobiliary disorders       
Bile duct stenosis   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Cholecystitis   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Immune system disorders       
Acute graft versus host disease   1/40 (2.50%)  0/40 (0.00%)  1/40 (2.50%) 
Lung transplant rejection   2/40 (5.00%)  1/40 (2.50%)  1/40 (2.50%) 
Infections and infestations       
Adenovirus infection   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Appendicitis   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Bacteraemia   1/40 (2.50%)  2/40 (5.00%)  0/40 (0.00%) 
Bacterial sepsis   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Bronchiolitis   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Clostridium difficile infection   2/40 (5.00%)  0/40 (0.00%)  1/40 (2.50%) 
Cytomegalovirus gastroenteritis   2/40 (5.00%)  0/40 (0.00%)  0/40 (0.00%) 
Cytomegalovirus infection   3/40 (7.50%)  5/40 (12.50%)  6/40 (15.00%) 
Encephalitis viral   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Escherichia bacteraemia   1/40 (2.50%)  0/40 (0.00%)  1/40 (2.50%) 
Pneumonia   1/40 (2.50%)  2/40 (5.00%)  1/40 (2.50%) 
Sepsis   2/40 (5.00%)  3/40 (7.50%)  1/40 (2.50%) 
Cytomegalovirus chorioretinitis   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Encephalitis cytomegalovirus   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Herpes simplex meningoencephalitis   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Klebsiella bacteraemia   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Parvovirus infection   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Urinary tract infection   0/40 (0.00%)  1/40 (2.50%)  1/40 (2.50%) 
Arteriovenous fistula site infection   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
Catheter site infection   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
Cellulitis   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
Nocardiosis   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
Pneumocystis jirovecii pneumonia   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
Pneumonia cytomegaloviral   1/40 (2.50%)  0/40 (0.00%)  2/40 (5.00%) 
Respiratory syncytial virus infection   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
Rhinovirus infection   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
Injury, poisoning and procedural complications       
Blood stem cell transplant failure   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Fall   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Investigations       
Oxygen saturation decreased   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
Immunosuppresant drug level increased   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
Metabolism and nutrition disorders       
Dehydration   1/40 (2.50%)  1/40 (2.50%)  2/40 (5.00%) 
Failure to thrive   1/40 (2.50%)  1/40 (2.50%)  1/40 (2.50%) 
Gout   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Hyponatraemia   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Fluid overload   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Hyperglycaemia   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
Hypokalaemia   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
Hyperkalaemia   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Leukaemia recurrent   2/40 (5.00%)  0/40 (0.00%)  1/40 (2.50%) 
Oesophageal carcinoma   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Post transplant lymphoproliferative disorder   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Nervous system disorders       
Central nervous system haemorrhage   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Encephalopathy   1/40 (2.50%)  1/40 (2.50%)  0/40 (0.00%) 
Spondylitic myelopathy   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Convulsion   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
Psychiatric disorders       
Mental status changes   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Renal and urinary disorders       
Acute prerenal failure   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Focal segmental glomerulosclerosis   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Renal impairment   2/40 (5.00%)  3/40 (7.50%)  2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Dyspnoea exertional   0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Acute respiratory distress syndrome   0/40 (0.00%)  0/40 (0.00%)  2/40 (5.00%) 
Diffuse alveolar damage   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
Respiratory failure   0/40 (0.00%)  0/40 (0.00%)  3/40 (7.50%) 
Vascular disorders       
Hypotension   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Jugular vein thrombosis   1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%) 
Orthostatic hypotension   0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Maribavir 400 mg Twice Daily Maribavir 800 mg Twice Daily Maribavir 1200 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   40/40 (100.00%)   40/40 (100.00%)   40/40 (100.00%) 
Blood and lymphatic system disorders       
Anaemia   3/40 (7.50%)  7/40 (17.50%)  10/40 (25.00%) 
Leukopenia   1/40 (2.50%)  3/40 (7.50%)  4/40 (10.00%) 
Thrombocytopenia   3/40 (7.50%)  3/40 (7.50%)  2/40 (5.00%) 
Leukocytosis   3/40 (7.50%)  1/40 (2.50%)  3/40 (7.50%) 
Haemolytic anaemia   1/40 (2.50%)  1/40 (2.50%)  3/40 (7.50%) 
Neutropenia   2/40 (5.00%)  1/40 (2.50%)  2/40 (5.00%) 
Coagulopathy   0/40 (0.00%)  2/40 (5.00%)  2/40 (5.00%) 
Cardiac disorders       
Sinus tachycardia   2/40 (5.00%)  2/40 (5.00%)  1/40 (2.50%) 
Angina pectoris   0/40 (0.00%)  3/40 (7.50%)  1/40 (2.50%) 
Tachycardia   2/40 (5.00%)  1/40 (2.50%)  1/40 (2.50%) 
Pericardial effusion   2/40 (5.00%)  0/40 (0.00%)  1/40 (2.50%) 
Atrial fibrillation   0/40 (0.00%)  0/40 (0.00%)  2/40 (5.00%) 
Left ventricular hypertrophy   0/40 (0.00%)  0/40 (0.00%)  2/40 (5.00%) 
Endocrine disorders       
Hypothyroidism   0/40 (0.00%)  3/40 (7.50%)  1/40 (2.50%) 
Eye disorders       
Visual impairment   0/40 (0.00%)  0/40 (0.00%)  3/40 (7.50%) 
Gastrointestinal disorders       
Nausea   14/40 (35.00%)  9/40 (22.50%)  12/40 (30.00%) 
Vomiting   11/40 (27.50%)  12/40 (30.00%)  11/40 (27.50%) 
Diarrhoea   5/40 (12.50%)  11/40 (27.50%)  10/40 (25.00%) 
Constipation   5/40 (12.50%)  5/40 (12.50%)  5/40 (12.50%) 
Abdominal pain   2/40 (5.00%)  4/40 (10.00%)  3/40 (7.50%) 
Ascites   3/40 (7.50%)  1/40 (2.50%)  3/40 (7.50%) 
Dyspepsia   2/40 (5.00%)  2/40 (5.00%)  1/40 (2.50%) 
Abdominal distension   1/40 (2.50%)  1/40 (2.50%)  2/40 (5.00%) 
Dysphagia   2/40 (5.00%)  1/40 (2.50%)  0/40 (0.00%) 
Proctalgia   2/40 (5.00%)  0/40 (0.00%)  0/40 (0.00%) 
General disorders       
Fatigue   7/40 (17.50%)  10/40 (25.00%)  7/40 (17.50%) 
Oedema peripheral   11/40 (27.50%)  5/40 (12.50%)  6/40 (15.00%) 
Pyrexia   4/40 (10.00%)  5/40 (12.50%)  3/40 (7.50%) 
Chills   2/40 (5.00%)  2/40 (5.00%)  4/40 (10.00%) 
Local swelling   2/40 (5.00%)  1/40 (2.50%)  2/40 (5.00%) 
Pain   2/40 (5.00%)  2/40 (5.00%)  1/40 (2.50%) 
Asthenia   1/40 (2.50%)  1/40 (2.50%)  2/40 (5.00%) 
Generalised oedema   0/40 (0.00%)  1/40 (2.50%)  2/40 (5.00%) 
Malaise   2/40 (5.00%)  0/40 (0.00%)  2/40 (5.00%) 
Gait disturbance   1/40 (2.50%)  2/40 (5.00%)  0/40 (0.00%) 
Swelling   2/40 (5.00%)  0/40 (0.00%)  0/40 (0.00%) 
Immune system disorders       
Acute graft versus host disease   1/40 (2.50%)  4/40 (10.00%)  2/40 (5.00%) 
Lung transplant rejection   2/40 (5.00%)  0/40 (0.00%)  0/40 (0.00%) 
Hypogammaglobulinaemia   2/40 (5.00%)  1/40 (2.50%)  1/40 (2.50%) 
Infections and infestations       
Cytomegalovirus infection   3/40 (7.50%)  8/40 (20.00%)  4/40 (10.00%) 
Pneumonia   5/40 (12.50%)  3/40 (7.50%)  4/40 (10.00%) 
Urinary tract infection   6/40 (15.00%)  2/40 (5.00%)  2/40 (5.00%) 
Clostridium difficile infection   2/40 (5.00%)  2/40 (5.00%)  4/40 (10.00%) 
Oral candidiasis   1/40 (2.50%)  1/40 (2.50%)  4/40 (10.00%) 
Upper respiratory tract infection   2/40 (5.00%)  3/40 (7.50%)  1/40 (2.50%) 
BK virus infection   3/40 (7.50%)  1/40 (2.50%)  1/40 (2.50%) 
Genital herpes   0/40 (0.00%)  2/40 (5.00%)  1/40 (2.50%) 
Klebsiella bacteraemia   0/40 (0.00%)  0/40 (0.00%)  2/40 (5.00%) 
Nasopharyngitis   1/40 (2.50%)  2/40 (5.00%)  0/40 (0.00%) 
Injury, poisoning and procedural complications       
Procedural complication   0/40 (0.00%)  2/40 (5.00%)  1/40 (2.50%) 
Fall   0/40 (0.00%)  2/40 (5.00%)  0/40 (0.00%) 
Investigations       
Immunosuppressant drug level increased   4/40 (10.00%)  2/40 (5.00%)  5/40 (12.50%) 
Weight decreased   2/40 (5.00%)  3/40 (7.50%)  4/40 (10.00%) 
Bacterial test positive   2/40 (5.00%)  3/40 (7.50%)  1/40 (2.50%) 
Blood creatinine increased   1/40 (2.50%)  3/40 (7.50%)  2/40 (5.00%) 
Hepatic enzyme increased   3/40 (7.50%)  3/40 (7.50%)  0/40 (0.00%) 
Blood alkaline phosphatase increased   1/40 (2.50%)  2/40 (5.00%)  0/40 (0.00%) 
Weight increased   2/40 (5.00%)  1/40 (2.50%)  0/40 (0.00%) 
Blood urea increased   0/40 (0.00%)  2/40 (5.00%)  0/40 (0.00%) 
Neutrophil count increased   0/40 (0.00%)  0/40 (0.00%)  2/40 (5.00%) 
Metabolism and nutrition disorders       
Decreased appetite   3/40 (7.50%)  5/40 (12.50%)  4/40 (10.00%) 
Dehydration   4/40 (10.00%)  3/40 (7.50%)  1/40 (2.50%) 
Hypokalaemia   2/40 (5.00%)  4/40 (10.00%)  5/40 (12.50%) 
Hyperkalaemia   2/40 (5.00%)  3/40 (7.50%)  4/40 (10.00%) 
Hyperglycaemia   2/40 (5.00%)  2/40 (5.00%)  2/40 (5.00%) 
Fluid overload   4/40 (10.00%)  1/40 (2.50%)  0/40 (0.00%) 
Hypocalcaemia   3/40 (7.50%)  1/40 (2.50%)  0/40 (0.00%) 
Hyponatraemia   0/40 (0.00%)  1/40 (2.50%)  2/40 (5.00%) 
Hypophosphataemia   2/40 (5.00%)  2/40 (5.00%)  0/40 (0.00%) 
Hypernatraemia   0/40 (0.00%)  2/40 (5.00%)  1/40 (2.50%) 
Hypervolaemia   0/40 (0.00%)  0/40 (0.00%)  2/40 (5.00%) 
Hypomagnesaemia   0/40 (0.00%)  0/40 (0.00%)  2/40 (5.00%) 
Musculoskeletal and connective tissue disorders       
Back pain   4/40 (10.00%)  1/40 (2.50%)  4/40 (10.00%) 
Arthralgia   3/40 (7.50%)  3/40 (7.50%)  2/40 (5.00%) 
Pain in extremity   1/40 (2.50%)  4/40 (10.00%)  0/40 (0.00%) 
Musculoskeletal pain   3/40 (7.50%)  0/40 (0.00%)  1/40 (2.50%) 
Myalgia   2/40 (5.00%)  1/40 (2.50%)  1/40 (2.50%) 
Neck pain   0/40 (0.00%)  3/40 (7.50%)  1/40 (2.50%) 
Nervous system disorders       
Dysgeusia   24/40 (60.00%)  25/40 (62.50%)  29/40 (72.50%) 
Headache   9/40 (22.50%)  4/40 (10.00%)  6/40 (15.00%) 
Dizziness   1/40 (2.50%)  5/40 (12.50%)  3/40 (7.50%) 
Neuropathy peripheral   1/40 (2.50%)  2/40 (5.00%)  2/40 (5.00%) 
Dysaesthesia   0/40 (0.00%)  1/40 (2.50%)  2/40 (5.00%) 
Somnolence   0/40 (0.00%)  1/40 (2.50%)  2/40 (5.00%) 
Psychiatric disorders       
Depression   2/40 (5.00%)  8/40 (20.00%)  1/40 (2.50%) 
Insomnia   2/40 (5.00%)  3/40 (7.50%)  1/40 (2.50%) 
Anxiety   0/40 (0.00%)  4/40 (10.00%)  1/40 (2.50%) 
Libido decreased   0/40 (0.00%)  0/40 (0.00%)  2/40 (5.00%) 
Renal and urinary disorders       
Renal impairment   1/40 (2.50%)  4/40 (10.00%)  7/40 (17.50%) 
Urinary incontinence   1/40 (2.50%)  3/40 (7.50%)  1/40 (2.50%) 
Proteinuria   0/40 (0.00%)  1/40 (2.50%)  2/40 (5.00%) 
Urinary retention   0/40 (0.00%)  0/40 (0.00%)  3/40 (7.50%) 
Respiratory, thoracic and mediastinal disorders       
Cough   5/40 (12.50%)  6/40 (15.00%)  2/40 (5.00%) 
Dyspnoea   4/40 (10.00%)  2/40 (5.00%)  5/40 (12.50%) 
Hypoxia   4/40 (10.00%)  2/40 (5.00%)  2/40 (5.00%) 
Oropharyngeal pain   2/40 (5.00%)  2/40 (5.00%)  0/40 (0.00%) 
Dyspnoea exertional   0/40 (0.00%)  0/40 (0.00%)  2/40 (5.00%) 
Haemoptysis   0/40 (0.00%)  1/40 (2.50%)  2/40 (5.00%) 
Nasal congestion   2/40 (5.00%)  0/40 (0.00%)  1/40 (2.50%) 
Pleural effusion   2/40 (5.00%)  0/40 (0.00%)  1/40 (2.50%) 
Rhinorrhoea   0/40 (0.00%)  3/40 (7.50%)  0/40 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash   7/40 (17.50%)  6/40 (15.00%)  3/40 (7.50%) 
Pruritus   5/40 (12.50%)  1/40 (2.50%)  5/40 (12.50%) 
Ecchymosis   1/40 (2.50%)  2/40 (5.00%)  1/40 (2.50%) 
Alopecia   2/40 (5.00%)  1/40 (2.50%)  0/40 (0.00%) 
Blood blister   2/40 (5.00%)  0/40 (0.00%)  1/40 (2.50%) 
Decubitus ulcer   0/40 (0.00%)  2/40 (5.00%)  1/40 (2.50%) 
Erythema   2/40 (5.00%)  1/40 (2.50%)  0/40 (0.00%) 
Night sweats   0/40 (0.00%)  2/40 (5.00%)  1/40 (2.50%) 
Skin lesion   0/40 (0.00%)  2/40 (5.00%)  0/40 (0.00%) 
Vascular disorders       
Hypotension   4/40 (10.00%)  5/40 (12.50%)  1/40 (2.50%) 
Hypertension   3/40 (7.50%)  3/40 (7.50%)  0/40 (0.00%) 
Flushing   1/40 (2.50%)  0/40 (0.00%)  2/40 (5.00%) 
Hot flush   0/40 (0.00%)  0/40 (0.00%)  2/40 (5.00%) 
Thrombophlebitis   0/40 (0.00%)  2/40 (5.00%)  0/40 (0.00%) 
Indicates events were collected by systematic assessment
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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Name/Title: Study Physician
Organization: Shire Development LLC
Phone: +1 866 842 5335
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01611974     History of Changes
Other Study ID Numbers: 1263-202
SHP620-202 ( Other Identifier: Shire Development LLC )
First Submitted: June 1, 2012
First Posted: June 5, 2012
Results First Submitted: November 13, 2015
Results First Posted: December 17, 2015
Last Update Posted: December 17, 2015