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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02062294
Other study ID # ML25224
Secondary ID
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


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
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