Cytomegalovirus (CMV) Infection

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 treatments 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 maribavirs 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 for participants in Japan who have Cytomegalovirus CMV infection that does not respond to existing anti-CMV treatments, especially after organ transplantation including hematopoietic stem cell transplantation. The study aims to see if Maribavir can protect against CMV infection and to monitor any side effects during treatment. The sponsor, Takeda, provides instructions but does not influence treatment decisions. Participants will take Maribavir tablets orally at a dose of 400 milligrams twice a day, following their clinics usual practice. The study does not control how treatment is given but collects information on how participants respond to Maribavir over a period of 27 weeks. This period allows researchers to observe the treatments effects and any adverse reactions. During the 27 weeks, study doctors will monitor participants closely for side effects and record safety data. They will also measure how the CMV infection responds to treatment, including viral clearance, resistance to Maribavir, graft rejection, graft-versus-host disease, and mortality rates. This observational study helps gather important information about Maribavirs impact on patients with difficult-to-treat CMV infection.

Opportunistic infections caused by viruses such as Epstein Barr Virus EBV, Cytomegalovirus CMV, adenovirus AdV, and BK virus BKV pose serious risks for patients undergoing hematopoietic stem cell transplantation HSCT or those who are immunocompromised. These infections often lead to significant illness and death, particularly during the early period after transplant. Traditional antimicrobial drugs are used to prevent and treat these infections, but some patients develop resistance, making treatment challenging. This study evaluates the safety and effectiveness of using microbial-specific cytotoxic T lymphocytes CTLs to treat these infections in such vulnerable patients. In this trial, researchers prepare CTLs from a patients own or a donors blood by activating and enriching T cells with pathogen-specific antigens. The prepared CTLs are infused intravenously at doses ranging from approximately 1x105 to 1x106 cells per kilogram of body weight. Patients may receive repeated CTL infusions to combat microbial infections. The process of preparing the CTLs takes about 12 to 17 days. This phase III trial focuses on evaluating the safety and monitoring the antimicrobial effects of these infused CTLs. Participants will be followed closely after infusion with weekly visits for one month, then monthly for three months, and subsequently every three months until the study concludes. During these visits, doctors will assess safety using standard criteria for adverse events and monitor viral loads to evaluate treatment response. Additional evaluations include immune system recovery, incidence of graft-versus-host disease-like symptoms, and other potential infusion-related effects. The total study duration extends up to the end of 2030, allowing for long-term monitoring of participants health and immune status.

Researchers are evaluating an individualized anti-thymocyte globulin ATG dosing strategy in adults undergoing unrelated donor allogeneic hematopoietic stem cell transplantation URD-HSCT to reduce complications like cytomegalovirus CMV reactivation. This phase 2 trial builds on previous findings in haploidentical peripheral blood stem cell transplantation, aiming to optimize ATG exposure and improve patient outcomes without increasing graft-versus-host disease GVHD or relapse. The study is sponsored by the Chinese PLA General Hospital and addresses the challenge of finding the best ATG dose considering various factors like donor type and conditioning intensity. The trial administers ATG over four days during conditioning, with fixed doses on days -5 and -4, and doses on days -3 and -2 adjusted based on active ATG concentration measurements to maintain an optimal drug exposure range. This targeted dosing approach seeks to balance effective GVHD prevention while minimizing risks of viral reactivation and other complications. Participants receive the individualized ATG regimen before their stem cell transplant, following specific timing and dosing protocols. Participants are monitored for CMV reactivation over 180 days after transplantation as the primary outcome. The study involves clinical assessments, blood tests for ATG levels and viral monitoring, and evaluations of overall safety and effectiveness. Researchers also track liver and kidney function, infection status, and physical condition. The total study duration includes the treatment period and follow-up to capture important transplant-related outcomes and adverse events.