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Trial record 21 of 102 for:    Valcyte

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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Cytomegalovirus Infections
Enrollment 14
Recruitment Details This study was conducted between 09 July 2010 and 22 September 2011 and recruited participants from 3 sites in Switzerland.
Pre-assignment Details A total of 14 participants who were CMV seronegative and had received a liver transplant from a CMV seropositive donor, received 900 mg Valganciclovir in this study.
Arm/Group Title Valganciclovir
Hide Arm/Group Description Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
Period Title: Overall Study
Started 14
Completed 14
Not Completed 0
Arm/Group Title Valganciclovir
Hide Arm/Group Description Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
1
   7.1%
Between 18 and 65 years
13
  92.9%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 14 participants
48
(17 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
5
  35.7%
Male
9
  64.3%
1.Primary Outcome
Title Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis
Hide Description Participants with clinical manifestation of CMV disease within 6 months after liver transplantation under Valcyte prophylaxis were evaluated.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population comprised all 14 participants receiving Valganciclovir within 10 days post-transplantation for at least 70 days and for whom source data from the time period between liver transplantation until 6 months post-transplantation was available.
Arm/Group Title Valganciclovir
Hide Arm/Group Description:
Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
3
2.Secondary Outcome
Title Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs)
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis population (SAP) comprised all 14 participants which entered study.
Arm/Group Title Valganciclovir
Hide Arm/Group Description:
Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
SAEs 6
AEs 10
Time Frame 6 months
Adverse Event Reporting Description Safety Analysis population (SAP) comprised all 14 participants which entered study.
 
Arm/Group Title Valganciclovir
Hide Arm/Group Description Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
All-Cause Mortality
Valganciclovir
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Valganciclovir
Affected / at Risk (%)
Total   6/14 (42.86%) 
Gastrointestinal disorders   
Diarrhoea  1  1/14 (7.14%) 
General disorders   
Pyrexia  1  1/14 (7.14%) 
Hepatobiliary disorders   
Bile Duct Stenosis  1  1/14 (7.14%) 
Immune system disorders   
Transplant Rejection  1  1/14 (7.14%) 
Infections and infestations   
Cytomegalovirus Syndrome  1  2/14 (14.29%) 
Hepatitis C  1  1/14 (7.14%) 
Injury, poisoning and procedural complications   
Incisional Hernia  1  1/14 (7.14%) 
Renal and urinary disorders   
Renal Failure Acute  1  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion  1  1/14 (7.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Valganciclovir
Affected / at Risk (%)
Total   10/14 (71.43%) 
Blood and lymphatic system disorders   
Leukopenia  1  1/14 (7.14%) 
Neutropenia  1  1/14 (7.14%) 
Eye disorders   
Eye oedema  1  1/14 (7.14%) 
Eye pruritus  1  1/14 (7.14%) 
Gastrointestinal disorders   
Abdominal pain  1  1/14 (7.14%) 
Anal fissure  1  1/14 (7.14%) 
Aphthous stomatitis  1  1/14 (7.14%) 
Constipation  1  1/14 (7.14%) 
Diarrhoea  1  1/14 (7.14%) 
Nausea  1  1/14 (7.14%) 
General disorders   
Fatigue  1  2/14 (14.29%) 
Influenza like illness  1  2/14 (14.29%) 
Oedema  1  1/14 (7.14%) 
Infections and infestations   
Clostridium difficile colitis  1  1/14 (7.14%) 
Cystitis  1  1/14 (7.14%) 
Cytomegalovirus syndrome  1  1/14 (7.14%) 
Herpes simplex  1  1/14 (7.14%) 
Nasopharyngitis  1  1/14 (7.14%) 
Paronychia  1  1/14 (7.14%) 
Rhinitis  1  1/14 (7.14%) 
Urinary tract infection  1  1/14 (7.14%) 
Injury, poisoning and procedural complications   
Incisional hernia  1  2/14 (14.29%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/14 (7.14%) 
Hyperkalaemia  1  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/14 (7.14%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  1/14 (7.14%) 
Pruritus  1  1/14 (7.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
Name/Title: Clinical Operations Department
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02062294     History of Changes
Other Study ID Numbers: ML25224
First Submitted: February 12, 2014
First Posted: February 13, 2014
Results First Submitted: January 14, 2016
Results First Posted: February 11, 2016
Last Update Posted: July 5, 2017