An Observational Study of Valcyte (Valganciclovir) in D+/R- Liver Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT02062294|
Recruitment Status : Completed
First Posted : February 13, 2014
Results First Posted : February 11, 2016
Last Update Posted : July 5, 2017
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|Official Title:||Retrospective Review of Valganciclovir Efficacy in Preventing CMV Disease in D+/R- Liver Transplant Recipients - A Non-Interventional Program|
|Actual Study Start Date :||July 31, 2010|
|Actual Primary Completion Date :||September 30, 2011|
|Actual Study Completion Date :||September 30, 2011|
- Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis [ Time Frame: 6 months ]Participants with clinical manifestation of CMV disease within 6 months after liver transplantation under Valcyte prophylaxis were evaluated.
- Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062294
|Inselspital Bern; Viszerale Chirurgie und Medizin|
|Bern, Switzerland, 3010|
|Genève, Switzerland, 1211|
|Universitätsspital Zürich; Klinik für Gastroenterologie und Hepatologie|
|Zürich, Switzerland, 8091|
|Study Director:||Clinical Trials||Hoffmann-La Roche|