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

Cytomegalovirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062294
• Other study ID #: ML25224
• Status: Completed
• Phase: N/A
• First received: February 12, 2014
• Last updated: January 14, 2016
• Start date: July 2010
• Est. completion date: September 2011

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cytomegalovirus Infections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 months	No
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.	6 months	No