Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 45 of 46 for:    congenital CMV

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.
 
ClinicalTrials.gov Identifier: NCT02062294
Recruitment Status : Completed
First Posted : February 13, 2014
Results First Posted : February 11, 2016
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date February 12, 2014
First Posted Date February 13, 2014
Results First Submitted Date January 14, 2016
Results First Posted Date February 11, 2016
Last Update Posted Date July 5, 2017
Actual Study Start Date July 31, 2010
Actual Primary Completion Date September 30, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 14, 2016)
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.
Original Primary Outcome Measures
 (submitted: February 12, 2014)
Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT02062294 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 14, 2016)
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.
Original Secondary Outcome Measures
 (submitted: February 12, 2014)
Safety: Incidence of adverse events [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of Valcyte (Valganciclovir) in D+/R- Liver Transplant Recipients
Official Title Retrospective Review of Valganciclovir Efficacy in Preventing CMV Disease in D+/R- Liver Transplant Recipients - A Non-Interventional Program
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Liver transplant recipients at high risk of developing Cytomegalovirus disease
Condition Cytomegalovirus Infections
Intervention Not Provided
Study Groups/Cohorts Cohort
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 12, 2014)
14
Original Actual Enrollment Same as current
Actual Study Completion Date September 30, 2011
Actual Primary Completion Date September 30, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02062294
Other Study ID Numbers ML25224
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date May 2017