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

Completed

• Conditions: Cytomegalovirus Infections

• Registration Number: NCT02062294
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-31
• Primary Completion: 2011-09-30
• Study Completion: 2011-09-30
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-13
• Results First Submitted: 2016-01-14
• Results First Submitted QC: 2016-01-14
• Results First Posted: 2016-02-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis	6 months	Participants with clinical manifestation of CMV disease within 6 months after liver transplantation under Valcyte prophylaxis were evaluated.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs)	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.

Trial Locations

Locations (3)

Inselspital Bern; Viszerale Chirurgie und Medizin; 🇨🇭 Bern, Switzerland

HUG; Transplantation; 🇨🇭 Genève, Switzerland

Universitätsspital Zürich; Klinik für Gastroenterologie und Hepatologie; 🇨🇭 Zürich, Switzerland