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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Liver transplant recipients at high risk of developing Cytomegalovirus disease
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital Bern; Viszerale Chirurgie und Medizin | Bern | 3010 | Switzerland | |||
| HUG; Transplantation |
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.
This study was conducted between 09 July 2010 and 22 September 2011 and recruited participants from 3 sites in Switzerland.
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| ID | Title | Description |
|---|---|---|
| FG000 | Valganciclovir | Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Valganciclovir | Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | participants | 6 months |
|
6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Valganciclovir | Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incisional Hernia | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations Department | Hoffmann-LaRoche | 800-821-8590 | switzerland.clinical-research@roche.com |
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| 6 months |
| Geneva |
| 1211 |
| Switzerland |
| Universitätsspital Zürich; Klinik für Gastroenterologie und Hepatologie | Zurich | 8091 | Switzerland |
| Participants |
|
| Age, Continuous | Median | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| 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. | Safety Analysis population (SAP) comprised all 14 participants which entered study. | Posted | Number | participants | 6 months |
|
|
|
| 6 |
| 14 |
| 10 |
| 14 |
| Transplant Rejection | Immune system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Cytomegalovirus Syndrome | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Hepatitis C | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Bile Duct Stenosis | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Cytomegalovirus syndrome | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Eye oedema | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.