An Observational Study of Valcyte (Valganciclovir) in D+/R- Liver Transplant Recipients

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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Key information

Conditions

Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital Bern; Viszerale Chirurgie und Medizin, Bern, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Retrospective Review of Valganciclovir Efficacy in Preventing CMV Disease in D+/R- Liver Transplant Recipients - A Non-Interventional Program

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Feb 13, 2014
Registry last updated: Jul 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed