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
1 other identifier
observational
14
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2010
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2011
CompletedFirst Submitted
Initial submission to the registry
February 12, 2014
CompletedFirst Posted
Study publicly available on registry
February 13, 2014
CompletedResults Posted
Study results publicly available
February 11, 2016
CompletedJuly 5, 2017
May 1, 2017
1.2 years
February 12, 2014
January 14, 2016
June 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs)
6 months
Study Arms (1)
Cohort
Eligibility Criteria
Liver transplant recipients at high risk of developing Cytomegalovirus disease
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Inselspital Bern; Viszerale Chirurgie und Medizin
Bern, 3010, Switzerland
HUG; Transplantation
Geneva, 1211, Switzerland
Universitätsspital Zürich; Klinik für Gastroenterologie und Hepatologie
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Operations Department
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2014
First Posted
February 13, 2014
Study Start
July 31, 2010
Primary Completion
September 30, 2011
Study Completion
September 30, 2011
Last Updated
July 5, 2017
Results First Posted
February 11, 2016
Record last verified: 2017-05