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

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

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.

Study Overview

• Status: Completed
• Conditions: Cytomegalovirus Infections

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern; Viszerale Chirurgie und Medizin
  • Genève, Switzerland, 1211
    • HUG; Transplantation
  • Zürich, Switzerland, 8091
    • Universitätsspital Zürich; Klinik für Gastroenterologie und Hepatologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Liver transplant recipients at high risk of developing Cytomegalovirus disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	6 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2010
• Primary Completion (Actual): September 30, 2011
• Study Completion (Actual): September 30, 2011

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: February 12, 2014
• First Posted (Estimate): February 13, 2014

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections
• Other Study ID Numbers: ML25224