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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02062294
Recruitment Status : Completed
First Posted : February 13, 2014
Results First Posted : February 11, 2016
Last Update Posted : July 5, 2017
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease
Cytomegalovirus Infections

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Retrospective
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


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Liver transplant recipients at high risk of developing Cytomegalovirus disease

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02062294

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Inselspital Bern; Viszerale Chirurgie und Medizin
Bern, Switzerland, 3010
HUG; Transplantation
Genève, Switzerland, 1211
Universitätsspital Zürich; Klinik für Gastroenterologie und Hepatologie
Zürich, Switzerland, 8091
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT02062294    
Other Study ID Numbers: ML25224
First Posted: February 13, 2014    Key Record Dates
Results First Posted: February 11, 2016
Last Update Posted: July 5, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases