Trial Outcomes & Findings for An Observational Study of Valcyte (Valganciclovir) in D+/R- Liver Transplant Recipients (NCT NCT02062294)
NCT ID: NCT02062294
Last Updated: 2017-07-05
Results Overview
Participants with clinical manifestation of CMV disease within 6 months after liver transplantation under Valcyte prophylaxis were evaluated.
Recruitment status
COMPLETED
Target enrollment
14 participants
Primary outcome timeframe
6 months
Results posted on
2017-07-05
Participant Flow
This study was conducted between 09 July 2010 and 22 September 2011 and recruited participants from 3 sites in Switzerland.
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.
Participant milestones
| Measure |
Valganciclovir
Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Observational Study of Valcyte (Valganciclovir) in D+/R- Liver Transplant Recipients
Baseline characteristics by cohort
| Measure |
Valganciclovir
n=14 Participants
Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
48 Years
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
Participants with clinical manifestation of CMV disease within 6 months after liver transplantation under Valcyte prophylaxis were evaluated.
Outcome measures
| Measure |
Valganciclovir
n=14 Participants
Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
|
|---|---|
|
Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis
|
3 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Safety Analysis population (SAP) comprised all 14 participants which entered study.
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.
Outcome measures
| Measure |
Valganciclovir
n=14 Participants
Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
|
|---|---|
|
Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs)
SAEs
|
6 participants
|
|
Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs)
AEs
|
10 participants
|
Adverse Events
Valganciclovir
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Valganciclovir
n=14 participants at risk
Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
|
|---|---|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Immune system disorders
Transplant Rejection
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Renal and urinary disorders
Renal Failure Acute
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Infections and infestations
Cytomegalovirus Syndrome
|
14.3%
2/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Infections and infestations
Hepatitis C
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
General disorders
Pyrexia
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
Other adverse events
| Measure |
Valganciclovir
n=14 participants at risk
Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Gastrointestinal disorders
Anal fissure
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
General disorders
Fatigue
|
14.3%
2/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
General disorders
Influenza like illness
|
14.3%
2/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
General disorders
Oedema
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Infections and infestations
Clostridium difficile colitis
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Infections and infestations
Cystitis
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Infections and infestations
Cytomegalovirus syndrome
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Infections and infestations
Herpes simplex
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Infections and infestations
Paronychia
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Infections and infestations
Rhinitis
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Eye disorders
Eye oedema
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Eye disorders
Eye pruritus
|
7.1%
1/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
14.3%
2/14 • 6 months
Safety Analysis population (SAP) comprised all 14 participants which entered study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER