Cytomegalovirus Infections
Conditions
Brief summary
This retrospective review will evaluate the efficacy of Valcyte (valganciclovir) in preventing Cytomegalovirus (CMV) disease in D+/R- liver transplant recipients. Data from eligible patients will be collected for the 6 months following transplantation.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Liver transplant recipients, \>/= 16 years of age * Transplantation between January 2004 and June 2009 * CMV seronegative recipient (R-) who received a liver transplant from a seropositive donor (D+) * Valganciclovir therapy for at least 70 days beginning within 10 days post transplantation * Assessment of CMV disease status within the first 6 months post transplantation
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis | 6 months | Participants with clinical manifestation of CMV disease within 6 months after liver transplantation under Valcyte prophylaxis were evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs) | 6 months | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. |
Countries
Switzerland
Participant flow
Recruitment details
This study was conducted between 09 July 2010 and 22 September 2011 and recruited participants from 3 sites in Switzerland.
Pre-assignment details
A total of 14 participants who were CMV seronegative and had received a liver transplant from a CMV seropositive donor, received 900 mg Valganciclovir in this study.
Participants by arm
| Arm | Count |
|---|---|
| Valganciclovir Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Valganciclovir |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 48 Years |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 14 |
| serious Total, serious adverse events | 6 / 14 |
Outcome results
Primary
Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis
Participants with clinical manifestation of CMV disease within 6 months after liver transplantation under Valcyte prophylaxis were evaluated.
Time frame: 6 months
Population: Per Protocol (PP) population comprised all 14 participants receiving Valganciclovir within 10 days post-transplantation for at least 70 days and for whom source data from the time period between liver transplantation until 6 months post-transplantation was available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valganciclovir | Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis | 3 participants |
Secondary
Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Time frame: 6 months
Population: Safety Analysis population (SAP) comprised all 14 participants which entered study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Valganciclovir | Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs) | SAEs | 6 participants |
| Valganciclovir | Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs) | AEs | 10 participants |