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

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

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

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

Primary: Number of Participants With BK Viral Load <600 Copies/mL — 13; 17 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: Occurrence of BK Viruria — 22; 26 Participants

Primary: Evidence of Reduction of BK Viruria and/or Clearance of BK Viremia — 11; 8 participants — p=0.53

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

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

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

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

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

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

Primary: Number of Participants With Adverse Events and Serious Adverse Events — 6; 3; 23; 12 Participants

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

Primary: The Number of Participants Who Have Completed >90% of Their Recommended Cytomegalovirus (CMV) Monitoring Tests in the DBS and Control Arms in the ITT Population — 27; 15…

Primary: Incidence of EBV or CMV Related Disease in Transplant Recipient — 2; 0 participants

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

Primary: Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant — 43.6; 23.9 Percentage of patients — p=<=0.0002

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

Primary: Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs — 56; 41; 6 Participants

Primary: The Number of Polyoma BK Viremia Patients — 5 Participants

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: a) CMV Viral Load — 100; 97.6; 86.36; NA percentage of agreement