Clinical Trial Search

Primary: Incidence of BKV Viremia in the Study Population of Screened Renal or Renal-pancreas Transplant Subjects — 58 Participants

Primary: Percent Change From Baseline in BK Virus Copies at 3 Months — 70.3; 69.1 Percent change of BK virus copies

Primary: Number of Adverse Events in Post-Transplant Patients With BK Virus Viruria — 1; 1; 1; 2 Participants

Primary: BK Viral Status in Saliva at Week 4 — 3; 6; 5; 1 Participants

Primary: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) — 17; 17; 16 Participants

Primary: Grade 3 and Serious Adverse Events — 0 Participants

Primary: Number of Patients Developing BK Infection at 6 Months Post-transplant — 25; 5 Participants

Primary: Number of Subjects Who Had a Sustained and Significant Reduction in Plasma Viral Load of Primary dsDNA Virus — 15; 18; 39; 13 Participants

Primary: Number of Patients Where a Suitable VST Line Could be Found — 80 Participants

Primary: Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log — 19.61; 10.80; 18.25 Weeks — p=0.1866

Primary: Number of Participants With Clinically Significant CMV Infection — 13; 4; 6; 4 Participants

Primary: Proportion of Subjects Achieving Greater Than 3- or 4-Fold Increases in Neutralizing Antibody Concentration (NAC) — .844; .938; .875; .906 proportion of participants

Primary: Number of Participants With All-Cause Mortality — 9; 27; 8 Participants

Primary: Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease — 3 Participants

Primary: Time to Engraftment (Days) Stratified by CMV DNaemia Occurring Before or After Neutrophil's Engraftment — 17; 19 days

Primary: Number of Participants With Clinically Significant AdV Infection — 3; 6; 6 Participants

Primary: Compare Incidence, Duration and Magnitude of CMV and EBV Viremia in Kidney Transplant Recipients Receiving valA vs. valG. — 16; 20; 8; 4 Participants

Primary: Number of Participants With Sustained Virological Response at Week 12 (SVR12) — 2; 2 participants

Primary: Change in Mean Hepatitis B Virus (HBV) DNA Levels — 10.290; 9.721; 3.669; 3.194 log10 copies/mL

Primary: Number of Participants With a DLT — 0; 0; 0; 3 Participants

Primary: Outcome of the Neutralization Test (Number of Subjects With Antibody Response Measured by Neutralization Assay) — 6; 14 Participants — p=<0.001

Primary: Number of Participants With BK Viral Load <600 Copies/mL — 13; 17 Participants

Primary: Number of Participants With Clinically Significant CMV Infection Through Week 24 Post-Transplant — 155; 78 Participants

Primary: Participants Will Experience Less BK Infection Episodes Based on Viruria Results.

Primary: The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7 — 49; 64 Participants

Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 5; 4; 5; 4 Participants

Primary: Percentage of Seroresponders Before and After the Challenge Vaccination — 45.5; 58.8; 85.2; 88.3 Percentage of participants

Primary: Area Under the Curve Following Administration of Oral Valacyclovir Suspension 20 mg/kg Every 8 Hours — 28.8 mgxh/l

Primary: Number of Participants With Viral Sequences Present in Malignant T Cells of Patients With Sézary Syndrome — 6 Participants

Primary: Percentage of Samples With BG Levels > 60pg/ml — 4; 5; 3; 3 percent of blood samples