Cytomegalovirus (CMV) Infection

Researchers are evaluating the safety and tolerability of intravenous brincidofovir (BCV) in adults and children with adenovirus (AdV) or cytomegalovirus (CMV) infections. This Phase IIa, open-label study aims to confirm the effects of multiple ascending doses of BCV in subjects with AdV viremia or CMV, addressing an important need for treatment options in these viral infections. Participants receive BCV through continuous intravenous infusion over 2 hours at doses of 0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg twice weekly, or 0.4 mg/kg once weekly for 4 weeks. The study includes four cohorts to assess different dosing regimens and monitors both adenovirus and cytomegalovirus infections. Throughout the study, researchers will monitor safety by tracking adverse events and laboratory tests for up to 19 weeks after starting BCV treatment. They will also evaluate antiviral effects up to 9 weeks. Participants undergo blood sampling for viral load assessments and safety labs. The total participation duration varies depending on follow-up assessments after treatment.

Researchers are evaluating oral letermovir in newborns with symptomatic congenital Cytomegalovirus (CMV) disease in a Phase 1, open-label, single-arm study. The study aims to determine how the drug is processed in the body and assess its safety in infants. The trial involves two groups of neonates, focusing on letermovir exposure and viral suppression alongside standard treatment with valganciclovir. In this study, Group 1 of 4 infants will receive a single oral dose of letermovir, followed by detailed blood testing over 24 hours to measure drug levels. Depending on these results, they will start a 14-day course of daily oral letermovir. Group 2 of 8 infants will start the 14-day letermovir course concurrently with valganciclovir treatment. Dosages may be adjusted based on observed drug exposure. Throughout, infants will also receive valganciclovir as standard care. Participants will have blood draws on multiple study days to monitor drug levels, safety labs, and CMV viral loads in blood, saliva, and urine. Pharmacokinetic profiles will be collected on several days, including Day 10. Adverse events will be tracked during treatment and for four weeks after the last dose. After the study, infants will continue valganciclovir therapy for approximately six months as part of routine care. The primary measure is the drug's plasma exposure over 24 hours through Day 14.

Cytomegalovirus (CMV) is a common virus that can cause serious illness, especially in people with weakened immune systems after a transplant. Researchers are evaluating the safety and effectiveness of LIVTENCITY (Maribavir), a medicine approved in South Korea for treating CMV infection in adults after transplantation. This observational study aims to learn how LIVTENCITY works in routine clinical practice for these patients. Participants who have CMV infection or disease after a transplant and are resistant or refractory to one or more prior therapies such as ganciclovir, valganciclovir, foscarnet, or cidofovir will be treated with LIVTENCITY tablets as decided by their doctors. The study will follow participants for up to 20 weeks while they receive treatment according to approved labeling. During this approximately 5-month period, participant information will be collected without fixed hospital visit requirements, though visiting the study doctor about six times is recommended. Researchers will monitor adverse events, drug reactions, and CMV viral clearance through PCR tests at weeks 2, 8, and the end of treatment. They will also assess symptom control and collect safety data throughout the study.

This research aims to understand the safety and effectiveness of Maribavir in adults and children aged 12 and older who have post-transplant cytomegalovirus (CMV) infection in routine clinical practice in Argentina. The study collects real-world data from medical records and during the conduct of the study to evaluate how Maribavir is used and its impact in this patient group. Participants include those who have received Maribavir treatment either after its marketing authorization or before through expanded access or compassionate use programs. Data will be collected both prospectively and retrospectively over an observation period of 16 weeks to monitor treatment outcomes and safety. During the study, participants will be monitored for adverse events from the start of treatment up to week 16. Researchers will also measure the clearance of CMV DNA in plasma, symptom control of CMV infection, and clinically relevant responses to treatment at weeks 8 and 16. The study involves no intervention beyond standard care, and all data are gathered through routine clinical practice observations.

Researchers are evaluating the safety of maribavir in adults who have severe chronic kidney disease (CKD) or end-stage renal disease (ESRD), including those on dialysis, and who have a refractory cytomegalovirus (CMV) infection after transplantation. This observational study collects already existing data from participants' medical records without changing their standard medical care or treatment. The study includes adults aged 18 years or older who have undergone solid organ or stem cell transplantation and have been treated with maribavir for refractory CMV infection. Data will be collected from the start of maribavir treatment through up to seven days after the last dose or until death or end of available data, whichever comes first. Participants include those with severe CKD or ESRD, including those on peritoneal or hemodialysis. Participants' medical records will be reviewed to monitor any adverse events from maribavir treatment during the study period, which can last up to four years. The main measurement is the number of participants experiencing adverse events, including those of special interest. This review will not affect participants' usual care, and no new treatments or interventions will be given as part of this study.

Cytomegalovirus (CMV) is a common virus that can cause serious illness in people with weakened immune systems, especially those who have undergone transplants. Researchers are evaluating the use of maribavir, a medicine approved for treating CMV infection in adults after transplant, to learn how safe and effective it is in adults with post-transplant CMV infection in Belgium according to Belgian reimbursement rules. This is a non-interventional observational study where participants with post-transplant CMV infection or disease, who are starting maribavir treatment for the first time in line with Belgian reimbursement criteria, will be observed. The study collects data prospectively for up to 2 years without fixed hospital visits, relying mainly on routine visits and contacts. Participants will have their medical and treatment data collected during routine care visits over 2 years. Researchers will monitor outcomes such as how many participants clear the CMV virus, treatment duration, time to viral clearance, drug resistance, recurrence after treatment, and any treatment-related adverse events. The study aims to reflect real-world use of maribavir in daily clinical practice.

Researchers are evaluating the safety, tolerability, and effectiveness of maribavir in Chinese adults who have received hematopoietic stem cell or organ transplants and have cytomegalovirus (CMV) infections that are resistant or unresponsive to standard treatments. The study also aims to understand the recurrence rate of CMV after maribavir treatment and monitor for viral mutations that could cause resistance to the drug. Participants will take maribavir tablets orally, 400 mg twice daily, for up to 8 weeks. The study is open-label and single-arm, meaning all participants receive maribavir without placebo comparison. Treatment effects and drug levels in the body will be closely observed during and after the treatment period. During the study, participants will visit the clinic 18 times for evaluations including vital signs, laboratory tests, and electrocardiograms. Researchers will track side effects, blood levels of the virus, symptom control, and any return of infection up to 20 weeks from starting the drug. The study also includes detailed blood sampling to measure how maribavir is processed in the body.

Researchers are evaluating the safety and feasibility of infusing donor-derived virus-specific T-cells selected by the cytokine capture system (CCS) in patients who have undergone hematopoietic stem cell transplantation (HSCT) and have treatment-resistant viral infections. This study focuses on infections caused by cytomegalovirus (CMV), Epstein-Barr virus (EBV), and adenovirus. The CCS technology has been used successfully in previous clinical studies in Germany and the UK. The study is conducted as a single-center, open-label, single-arm trial where donor-derived interferon-gamma (IFN-B3) positive T-cells are generated and infused into HSCT recipients with viral infections. Six patients from the University Hospital of Basel will be included. If safety is confirmed, future studies will explore the treatment's efficacy and expand its use to other pathogens and patient groups, including solid organ transplant recipients. Participants will receive the selected IFN-B3 positive T-cell infusions and be closely monitored. Researchers will assess the level of enriched IFN-B3 positive T-cells within 7 days and evaluate treatment efficacy at the same timepoint. Safety and viral response will be regularly checked during the study. The trial started in December 2014 and is expected to continue until December 2026.

Researchers are studying the safety, tolerability, and how the body processes maribavir in children and teenagers who have cytomegalovirus (CMV) infection after receiving a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT). This phase 3 trial aims to find the best dose of maribavir using either a 200 mg tablet or a powder for oral suspension formulation. The study focuses on these young patients who have documented CMV infection and evaluates maribavir's antiviral activity along with its pharmacokinetics. Participants receive maribavir for up to 8 weeks with doses adjusted based on age and body weight. For ages 12 to less than 18 years, dosing ranges from 100 mg to 400 mg twice daily depending on weight. Those aged 6 to less than 12 years follow a similar dosing scheme, and children younger than 6 years may receive doses from 50 mg once or twice daily up to 400 mg twice daily. The medication is taken orally as tablets or powder for oral suspension during the treatment period. During the study, participants will have multiple blood tests to measure maribavir levels at various time points, and adverse events will be monitored up to 20 weeks. There is a 12-week follow-up period after treatment ends, during which participants will visit their doctor to assess continued viral control and safety. Researchers will also evaluate the clearance of CMV viremia, recurrence rates, and resistance development, along with participant feedback on medication palatability.

Researchers are evaluating Maribavir tablets in people with Cytomegalovirus (CMV) infection that does not respond to existing anti-CMV treatments after organ transplantation, including stem cell transplants. The study aims to see if Maribavir can help protect Japanese patients from CMV infection and to monitor any side effects from this treatment. Participants will take Maribavir tablets at a dose of 400 milligrams twice daily, following their clinic's usual care practice. The study is observational, meaning the sponsor will provide guidance on recording treatment effects but will not control how clinics deliver the medication. During the 27-week study period, doctors will observe and record any side effects from Maribavir. They will also monitor outcomes such as clearance of CMV in the blood, response to treatment, resistance to the drug, graft rejection, graft-versus-host disease, and overall survival. Participants will be involved in regular monitoring and assessments throughout the study duration.