Trial Outcomes & Findings for Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients (NCT NCT00497796)
NCT ID: NCT00497796
Last Updated: 2021-06-11
Results Overview
All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction \[PCR\] assay in plasma) and fever \>/=38 °C on \>/=2 occasions \>/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell \[WBC\] count \<3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was \>4000/mm3) \>/=24 hours apart, atypical lymphocytosis \>/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.
COMPLETED
PHASE3
307 participants
6 months post-transplant
2021-06-11
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
160
|
|
Overall Study
COMPLETED
|
62
|
101
|
|
Overall Study
NOT COMPLETED
|
85
|
59
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Adverse event (not related)
|
9
|
9
|
|
Overall Study
Adverse event (related)
|
5
|
4
|
|
Overall Study
CMV infection or disease treatment
|
30
|
4
|
|
Overall Study
Consent withdrawn
|
10
|
3
|
|
Overall Study
Investigator/sponsor discretion
|
31
|
34
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Not applicable (randomized not treated)
|
0
|
4
|
Baseline Characteristics
Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients
Baseline characteristics by cohort
| Measure |
Maribavir 100 mg BID
n=147 Participants
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
n=156 Participants
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
Total
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
53 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
54 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Distribution of age
18 to 44 years
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Distribution of age
45 to 64 years
|
109 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Distribution of age
65 to 75 years
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post-transplantPopulation: The modified Intent-to-Treat (ITT-M) population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.
All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction \[PCR\] assay in plasma) and fever \>/=38 °C on \>/=2 occasions \>/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell \[WBC\] count \<3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was \>4000/mm3) \>/=24 hours apart, atypical lymphocytosis \>/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.
Outcome measures
| Measure |
Maribavir 100 mg BID
n=113 Participants
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
n=120 Participants
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
|---|---|---|
|
Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation
|
14 number of participants with event
|
10 number of participants with event
|
SECONDARY outcome
Timeframe: 6 months post-transplantPopulation: The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.
Incidence of CMV infection or EC-confirmed CMV disease within the 6-month post-transplant period included in this section were defined (1) with infection assessed by pp65 antigenemia assay; (2) with infection assessed by CMV DNA PCR; (3) with infection assessed by either assay (pp65 antigenemia or CMV DNA PCR); and (4) with infection assessed by initiation of anti-CMV therapy.
Outcome measures
| Measure |
Maribavir 100 mg BID
n=113 Participants
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
n=120 Participants
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
|---|---|---|
|
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation
CMV DNA PCR assay
|
72 participants
|
52 participants
|
|
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation
pp65 antigenemia assay
|
63 participants
|
49 participants
|
|
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation
pp65 antigenemia or CMV DNA PCR assay
|
81 participants
|
64 participants
|
|
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation
Initiation of anti-CMV therapy
|
46 participants
|
39 participants
|
SECONDARY outcome
Timeframe: 6 months post-transplantPopulation: The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.
All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease) were adjudicated by an independent, blinded EC. CMV infection was assessed by pp65 Antigenemia or CMV DNA PCR from a central or local lab. CMV organ disease was defined as described by Ljungman et al., 2002.
Outcome measures
| Measure |
Maribavir 100 mg BID
n=113 Participants
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
n=120 Participants
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
|---|---|---|
|
Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation
|
45 days
Interval 41.0 to 68.0
|
127 days
Interval 125.0 to 161.0
|
SECONDARY outcome
Timeframe: Through 6 months post-transplant (Day 1 to 100 days and 6 months post-transplant)Population: The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.
Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction \[PCR\] assay in plasma) and fever \>/=38 °C on \>/=2 occasions \>/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell \[WBC\] count \<3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was \>4000/mm3) \>/=24 hours apart, atypical lymphocytosis \>/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.
Outcome measures
| Measure |
Maribavir 100 mg BID
n=113 Participants
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
n=120 Participants
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
|---|---|---|
|
Number of Participants With Investigator-determined CMV Disease
6 months post-transplant
|
22 participants
|
18 participants
|
|
Number of Participants With Investigator-determined CMV Disease
100 days post-transplant
|
17 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 100 days post-transplantPopulation: The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.
All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction \[PCR\] assay in plasma) and fever \>/=38 °C on \>/=2 occasions \>/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell \[WBC\] count \<3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was \>4000/mm3) \>/=24 hours apart, atypical lymphocytosis \>/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.
Outcome measures
| Measure |
Maribavir 100 mg BID
n=113 Participants
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
n=120 Participants
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
|---|---|---|
|
Number of Participants With EC-confirmed CMV Disease Within 100 Days Post-Transplantation
|
10 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 100 days post-transplantPopulation: The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.
Incidence of CMV infection or EC-confirmed CMV disease within the 6-month post-transplant period included in this section were defined (1) with infection assessed by pp65 antigenemia assay; (2) with infection assessed by CMV DNA PCR; (3) with infection assessed by either assay (pp65 antigenemia or CMV DNA PCR); and (4) with infection assessed by initiation of anti-CMV therapy.
Outcome measures
| Measure |
Maribavir 100 mg BID
n=113 Participants
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
n=120 Participants
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
|---|---|---|
|
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation
pp65 antigenemia assay
|
49 participants
|
19 participants
|
|
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation
CMV DNA PCR assay
|
59 participants
|
18 participants
|
|
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation
pp65 antigenemia or CMV DNA PCR assay
|
68 participants
|
24 participants
|
|
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation
Initiation of anti-CMV therapy
|
37 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant)Population: The ITT-Safety (ITT-S) population, defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Maribavir 100 mg BID
n=147 Participants
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
n=156 Participants
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
|---|---|---|
|
Number of Participants With Retransplantation
At 100 days post-transplant
|
1 participants
|
2 participants
|
|
Number of Participants With Retransplantation
At 6 months post-transplant
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant)Population: The ITT-S population, defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Maribavir 100 mg BID
n=147 Participants
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
n=156 Participants
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
|---|---|---|
|
Number of Participants With Graft Failure Related Death
100 days post-transplant
|
0 participants
|
2 participants
|
|
Number of Participants With Graft Failure Related Death
6 months post-transplant
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 26 weeks post-transplantPopulation: The ITT-S population, defined as all participants who received at least one dose of study drug.
Rejection was assessed by examining a liver biopsy sample. Diagnosis of graft rejection included a global assessment grade and a rejection activity index score.
Outcome measures
| Measure |
Maribavir 100 mg BID
n=147 Participants
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
n=156 Participants
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
|---|---|---|
|
Number of Participants With Acute Graft Rejection
100 days post-transplant
|
16 participants
|
19 participants
|
|
Number of Participants With Acute Graft Rejection
6 months post-transplant
|
20 participants
|
23 participants
|
SECONDARY outcome
Timeframe: 6 months post-transplantPopulation: The ITT-S population, defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Maribavir 100 mg BID
n=147 Participants
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
n=156 Participants
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
|---|---|---|
|
Number of Participants Who Died Within 6 Months Post-Transplantation
|
9 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 15 weeksPopulation: The ITT-S population, defined as all participants who received at least one dose of study drug.
Bone marrow suppression was assessed by the occurrence of adverse events (AEs) of investigator-reported leukopenia, neutropenia, thrombocytopenia, and pancytopenia; absolute neutrophil count (ANC) \<1000/mm3; white blood cell (WBC) count toxicity grade shifts from 0-2 at baseline to a maximum of 3-4 post-baseline; and use of hematopoietic growth factors during the 6 month post-transplant period.
Outcome measures
| Measure |
Maribavir 100 mg BID
n=147 Participants
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
n=156 Participants
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
|---|---|---|
|
Percent of Participants With Signs of Bone Marrow Suppression
Hematology AEs
|
14 percent of participants
|
21 percent of participants
|
|
Percent of Participants With Signs of Bone Marrow Suppression
ANC <1000/mm3
|
9 percent of participants
|
16 percent of participants
|
|
Percent of Participants With Signs of Bone Marrow Suppression
WBC count toxicity grade shifts
|
16 percent of participants
|
21 percent of participants
|
|
Percent of Participants With Signs of Bone Marrow Suppression
Use of hematopoietic growth factors
|
15 percent of participants
|
20 percent of participants
|
SECONDARY outcome
Timeframe: 12 hours post-dose after 2, 6, and 10 weeks of treatmentPopulation: The Pharmacokinetic (PK) population, defined as those participants in the ITT-S population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.
For the first 16 subjects to have PK profiling performed, PK sampling was collected at Weeks 2, 6 and 10. For subsequent subjects that have PK profiling performed, PK sampling was collected at Weeks 2 and 6. Samples were collected 12 hours after the morning dose of maribavir. Permissible assessment windows for pharmacokinetic profile sampling purposes were +/- 5 days for each sampling day. Samples for determination of maribavir concentration were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. For plasma, the minimum detectable concentration for maribavir was 0.2 μg/mL.
Outcome measures
| Measure |
Maribavir 100 mg BID
n=11 Participants
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
|---|---|---|
|
Plasma Concentration of Maribavir During Treatment
2 weeks, n=10
|
1.65 μg/mL
Standard Deviation 2.01
|
—
|
|
Plasma Concentration of Maribavir During Treatment
6 weeks, n=7
|
1.36 μg/mL
Standard Deviation 1.25
|
—
|
|
Plasma Concentration of Maribavir During Treatment
10 weeks, n=8
|
1.55 μg/mL
Standard Deviation 1.17
|
—
|
SECONDARY outcome
Timeframe: 12 hours post-dose after 2, 6, and 10 weeks of treatmentPopulation: The PK population, defined as those participants in the ITT-S population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.
For the first 16 subjects to have PK profiling performed, PK sampling was collected at Weeks 2, 6 and 10. For subsequent subjects that have PK profiling performed, PK sampling was collected at Weeks 2 and 6. Samples were collected 12 hours after the morning dose of maribavir. Permissible assessment windows for pharmacokinetic profile sampling purposes were +/- 5 days for each sampling day. Samples for determination of VP 44469 (a metabolite of maribavir) concentration were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. For plasma, the minimum detectable concentration for VP 44469 was 0.2 μg/mL.
Outcome measures
| Measure |
Maribavir 100 mg BID
n=11 Participants
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
|---|---|---|
|
Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment
2 weeks, n=10
|
0.609 μg/mL
Standard Deviation 0.648
|
—
|
|
Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment
6 weeks, n=7
|
0.506 μg/mL
Standard Deviation 0.224
|
—
|
|
Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment
10 weeks, n=8
|
0.666 μg/mL
Standard Deviation 0.656
|
—
|
Adverse Events
Maribavir 100 mg BID
Ganciclovir 1000 mg TID
Serious adverse events
| Measure |
Maribavir 100 mg BID
n=147 participants at risk
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
n=156 participants at risk
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.68%
1/147
|
2.6%
4/156
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.68%
1/147
|
0.64%
1/156
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.68%
1/147
|
0.00%
0/156
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/147
|
0.64%
1/156
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/147
|
0.64%
1/156
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/147
|
0.64%
1/156
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/147
|
0.64%
1/156
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/147
|
0.64%
1/156
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/147
|
0.64%
1/156
|
|
Cardiac disorders
Cardiac Failure
|
0.68%
1/147
|
0.00%
0/156
|
|
Cardiac disorders
Myocardial Infarction
|
0.68%
1/147
|
1.3%
2/156
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.68%
1/147
|
0.00%
0/156
|
|
Endocrine disorders
Diabetes Mellitus
|
1.4%
2/147
|
0.00%
0/156
|
|
Eye disorders
Cataract
|
0.68%
1/147
|
0.00%
0/156
|
|
Eye disorders
Ulcerative Keratitis
|
0.68%
1/147
|
0.00%
0/156
|
|
Gastrointestinal disorders
Abdominal Abscess
|
0.68%
1/147
|
0.64%
1/156
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.68%
1/147
|
1.3%
2/156
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/147
|
0.64%
1/156
|
|
Gastrointestinal disorders
Abdominal Strangulated Hernia
|
0.00%
0/147
|
0.64%
1/156
|
|
Gastrointestinal disorders
Clostridium Difficile Colitis
|
2.0%
3/147
|
1.9%
3/156
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.00%
0/147
|
0.64%
1/156
|
|
Gastrointestinal disorders
Constipation
|
0.68%
1/147
|
0.00%
0/156
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
2/147
|
2.6%
4/156
|
|
Gastrointestinal disorders
Diverticulitis
|
0.68%
1/147
|
0.00%
0/156
|
|
Gastrointestinal disorders
Fungal Peritonitis
|
0.00%
0/147
|
0.64%
1/156
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/147
|
1.3%
2/156
|
|
Gastrointestinal disorders
Ileus
|
0.68%
1/147
|
0.00%
0/156
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/147
|
1.9%
3/156
|
|
Gastrointestinal disorders
Intra-Abdominal Haemorrhage
|
0.68%
1/147
|
0.00%
0/156
|
|
Gastrointestinal disorders
Nausea
|
0.68%
1/147
|
1.3%
2/156
|
|
Gastrointestinal disorders
Obstruction Gastric
|
0.68%
1/147
|
0.00%
0/156
|
|
Gastrointestinal disorders
Oesophageal Candidiasis
|
0.68%
1/147
|
0.00%
0/156
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/147
|
0.64%
1/156
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/147
|
1.3%
2/156
|
|
Gastrointestinal disorders
Peritonitis
|
0.68%
1/147
|
1.3%
2/156
|
|
Gastrointestinal disorders
Umbilical Hernia
|
1.4%
2/147
|
0.64%
1/156
|
|
Gastrointestinal disorders
Vomiting
|
0.68%
1/147
|
1.9%
3/156
|
|
General disorders
Asthenia
|
0.00%
0/147
|
0.64%
1/156
|
|
General disorders
Non-Cardiac Chest Pain
|
0.68%
1/147
|
0.00%
0/156
|
|
General disorders
Oedema
|
0.68%
1/147
|
0.00%
0/156
|
|
General disorders
Oedema Peripheral
|
1.4%
2/147
|
0.00%
0/156
|
|
General disorders
Pyrexia
|
2.7%
4/147
|
4.5%
7/156
|
|
Hepatobiliary disorders
Alcoholic Liver Disease
|
0.68%
1/147
|
0.00%
0/156
|
|
Hepatobiliary disorders
Ascites
|
2.0%
3/147
|
2.6%
4/156
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
0.00%
0/147
|
0.64%
1/156
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
2.7%
4/147
|
1.3%
2/156
|
|
Hepatobiliary disorders
Cholangitis
|
2.0%
3/147
|
1.3%
2/156
|
|
Hepatobiliary disorders
Cholestasis
|
2.0%
3/147
|
0.00%
0/156
|
|
Hepatobiliary disorders
Cytolytic Hepatitis
|
0.00%
0/147
|
0.64%
1/156
|
|
Hepatobiliary disorders
Hepatic Artery Aneurysm
|
0.00%
0/147
|
1.3%
2/156
|
|
Hepatobiliary disorders
Hepatic Artery Occlusion
|
0.00%
0/147
|
1.3%
2/156
|
|
Hepatobiliary disorders
Hepatic Artery Stenosis
|
0.68%
1/147
|
0.00%
0/156
|
|
Hepatobiliary disorders
Hepatic Artery Thrombosis
|
0.68%
1/147
|
1.9%
3/156
|
|
Hepatobiliary disorders
Hepatic Haematoma
|
0.68%
1/147
|
0.00%
0/156
|
|
Hepatobiliary disorders
Hepatic Necrosis
|
0.00%
0/147
|
0.64%
1/156
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/147
|
0.64%
1/156
|
|
Hepatobiliary disorders
Hepatitis C
|
1.4%
2/147
|
1.9%
3/156
|
|
Hepatobiliary disorders
Liver Abscess
|
0.68%
1/147
|
0.64%
1/156
|
|
Hepatobiliary disorders
Portal Hypertension
|
0.00%
0/147
|
0.64%
1/156
|
|
Hepatobiliary disorders
Post Procedural Bile Leak
|
2.7%
4/147
|
1.3%
2/156
|
|
Immune system disorders
Acute Graft Versus Host Disease
|
0.68%
1/147
|
0.64%
1/156
|
|
Immune system disorders
Hypersensitivity
|
0.68%
1/147
|
0.00%
0/156
|
|
Immune system disorders
Liver Transplant Rejection
|
2.7%
4/147
|
7.7%
12/156
|
|
Infections and infestations
Abdominal Sepsis
|
0.00%
0/147
|
0.64%
1/156
|
|
Infections and infestations
Bacterial Sepsis
|
0.00%
0/147
|
0.64%
1/156
|
|
Infections and infestations
Cytomegalovirus Gastroenteritis
|
1.4%
2/147
|
0.64%
1/156
|
|
Infections and infestations
Cytomegalovirus Hepatitis
|
1.4%
2/147
|
0.00%
0/156
|
|
Infections and infestations
Cytomegalovirus Infection
|
8.2%
12/147
|
1.3%
2/156
|
|
Infections and infestations
Pneumonia Cytomegaloviral
|
1.4%
2/147
|
0.00%
0/156
|
|
Infections and infestations
Sepsis
|
0.68%
1/147
|
1.3%
2/156
|
|
Injury, poisoning and procedural complications
Complications Of Transplanted Liver
|
0.68%
1/147
|
0.00%
0/156
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/147
|
0.64%
1/156
|
|
Injury, poisoning and procedural complications
Incision Site Cellulitis
|
0.00%
0/147
|
0.64%
1/156
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
0.00%
0/147
|
0.64%
1/156
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.68%
1/147
|
0.00%
0/156
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.68%
1/147
|
0.00%
0/156
|
|
Injury, poisoning and procedural complications
Postoperative Wound Infection
|
0.00%
0/147
|
0.64%
1/156
|
|
Injury, poisoning and procedural complications
Therapeutic Agent Toxicity
|
0.00%
0/147
|
0.64%
1/156
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/147
|
0.64%
1/156
|
|
Injury, poisoning and procedural complications
Wound Infection
|
2.0%
3/147
|
1.9%
3/156
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
0.68%
1/147
|
0.64%
1/156
|
|
Investigations
Band Neutrophil Count Increased
|
0.00%
0/147
|
0.64%
1/156
|
|
Investigations
Biopsy Liver Abnormal
|
0.68%
1/147
|
0.00%
0/156
|
|
Investigations
Blood Bilirubin Increased
|
0.68%
1/147
|
0.64%
1/156
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/147
|
0.64%
1/156
|
|
Investigations
Hepatic Enzyme Increased
|
5.4%
8/147
|
2.6%
4/156
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/147
|
0.64%
1/156
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
2/147
|
0.64%
1/156
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.68%
1/147
|
0.00%
0/156
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.68%
1/147
|
1.9%
3/156
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/147
|
0.64%
1/156
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/147
|
0.64%
1/156
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.68%
1/147
|
0.00%
0/156
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/147
|
0.64%
1/156
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/147
|
0.64%
1/156
|
|
Musculoskeletal and connective tissue disorders
Arthritis Fungal
|
0.00%
0/147
|
0.64%
1/156
|
|
Musculoskeletal and connective tissue disorders
Femoral Neck Fracture
|
0.68%
1/147
|
0.00%
0/156
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/147
|
0.64%
1/156
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.68%
1/147
|
0.00%
0/156
|
|
Nervous system disorders
Convulsion
|
0.68%
1/147
|
0.64%
1/156
|
|
Nervous system disorders
Dizziness
|
0.00%
0/147
|
0.64%
1/156
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.68%
1/147
|
0.00%
0/156
|
|
Nervous system disorders
Hypoglycaemic Seizure
|
0.00%
0/147
|
0.64%
1/156
|
|
Psychiatric disorders
Adjustment Disorder
|
0.68%
1/147
|
0.00%
0/156
|
|
Psychiatric disorders
Bipolar Disorder
|
0.68%
1/147
|
0.00%
0/156
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/147
|
0.64%
1/156
|
|
Psychiatric disorders
Delirium
|
0.00%
0/147
|
1.3%
2/156
|
|
Psychiatric disorders
Mental Status Changes
|
0.68%
1/147
|
0.00%
0/156
|
|
Psychiatric disorders
Psychotic Disorder
|
0.68%
1/147
|
0.64%
1/156
|
|
Renal and urinary disorders
Mesangioproliferative Glomerulonephritis
|
0.68%
1/147
|
0.00%
0/156
|
|
Renal and urinary disorders
Nephritis Interstitial
|
0.00%
0/147
|
0.64%
1/156
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.68%
1/147
|
0.00%
0/156
|
|
Renal and urinary disorders
Renal Failure
|
2.7%
4/147
|
1.9%
3/156
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.68%
1/147
|
0.64%
1/156
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/147
|
0.64%
1/156
|
|
Respiratory, thoracic and mediastinal disorders
Lung Neoplasm Malignant
|
0.00%
0/147
|
0.64%
1/156
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.4%
2/147
|
1.9%
3/156
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Infection
|
0.68%
1/147
|
0.00%
0/156
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/147
|
0.64%
1/156
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.4%
2/147
|
0.64%
1/156
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Staphylococcal
|
0.68%
1/147
|
0.00%
0/156
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/147
|
0.64%
1/156
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.68%
1/147
|
0.00%
0/156
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
1.4%
2/147
|
0.00%
0/156
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.68%
1/147
|
0.00%
0/156
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Syncytial Virus Infection
|
0.00%
0/147
|
0.64%
1/156
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
0.68%
1/147
|
0.00%
0/156
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.68%
1/147
|
1.3%
2/156
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.68%
1/147
|
0.00%
0/156
|
|
Vascular disorders
Arterial Haemorrhage
|
0.00%
0/147
|
0.64%
1/156
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.68%
1/147
|
0.00%
0/156
|
|
Vascular disorders
Hypotension
|
0.68%
1/147
|
0.00%
0/156
|
|
Vascular disorders
Syncope
|
0.00%
0/147
|
0.64%
1/156
|
|
Vascular disorders
Thrombophlebitis
|
0.68%
1/147
|
0.00%
0/156
|
Other adverse events
| Measure |
Maribavir 100 mg BID
n=147 participants at risk
Maribavir: 100mg twice a day (BID) for 14 weeks.
|
Ganciclovir 1000 mg TID
n=156 participants at risk
Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.1%
9/147
|
8.3%
13/156
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.4%
8/147
|
3.2%
5/156
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.2%
12/147
|
12.2%
19/156
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.4%
8/147
|
6.4%
10/156
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/147
|
5.1%
8/156
|
|
Gastrointestinal disorders
Abdominal Pain
|
8.2%
12/147
|
9.6%
15/156
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
4.8%
7/147
|
5.1%
8/156
|
|
Gastrointestinal disorders
Constipation
|
6.1%
9/147
|
7.1%
11/156
|
|
Gastrointestinal disorders
Diarrhoea
|
27.9%
41/147
|
23.1%
36/156
|
|
Gastrointestinal disorders
Dysgeusia
|
15.0%
22/147
|
12.8%
20/156
|
|
Gastrointestinal disorders
Nausea
|
9.5%
14/147
|
17.9%
28/156
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
14/147
|
9.6%
15/156
|
|
General disorders
Asthenia
|
0.68%
1/147
|
5.1%
8/156
|
|
General disorders
Fatigue
|
6.8%
10/147
|
11.5%
18/156
|
|
General disorders
Oedema Peripheral
|
12.9%
19/147
|
9.6%
15/156
|
|
General disorders
Pyrexia
|
10.2%
15/147
|
8.3%
13/156
|
|
Hepatobiliary disorders
Ascites
|
6.1%
9/147
|
4.5%
7/156
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
6.1%
9/147
|
5.8%
9/156
|
|
Hepatobiliary disorders
Hepatitis C
|
9.5%
14/147
|
4.5%
7/156
|
|
Immune system disorders
Liver Transplant Rejection
|
7.5%
11/147
|
5.1%
8/156
|
|
Investigations
Hepatic Enzyme Increased
|
10.9%
16/147
|
8.3%
13/156
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
9.5%
14/147
|
3.8%
6/156
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.9%
19/147
|
13.5%
21/156
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.4%
8/147
|
2.6%
4/156
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.5%
14/147
|
7.7%
12/156
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
4/147
|
5.1%
8/156
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.8%
13/147
|
7.1%
11/156
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.0%
3/147
|
5.1%
8/156
|
|
Nervous system disorders
Dizziness
|
2.0%
3/147
|
7.7%
12/156
|
|
Nervous system disorders
Headache
|
13.6%
20/147
|
18.6%
29/156
|
|
Nervous system disorders
Insomnia
|
8.8%
13/147
|
10.9%
17/156
|
|
Nervous system disorders
Tremor
|
17.0%
25/147
|
12.8%
20/156
|
|
Psychiatric disorders
Anxiety
|
7.5%
11/147
|
2.6%
4/156
|
|
Renal and urinary disorders
Renal Failure
|
8.2%
12/147
|
7.1%
11/156
|
|
Renal and urinary disorders
Urinary Tract Infection
|
15.0%
22/147
|
7.1%
11/156
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
5/147
|
5.8%
9/156
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.1%
9/147
|
4.5%
7/156
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.1%
9/147
|
7.7%
12/156
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
8/147
|
4.5%
7/156
|
|
Vascular disorders
Hypertension
|
12.2%
18/147
|
13.5%
21/156
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER