Maribavir

DRUG18 trials

Sponsors

Takeda Development Center Americas Inc., Glaxo Wellcome, Shire, Takeda, Medical University of South Carolina

Conditions

CMVCytomegalovirus (CMV)Cytomegalovirus (CMV) infection in children and adolescents who have received a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT)Cytomegalovirus InfectionCytomegalovirus InfectionsHIV InfectionsHealthy VolunteersInfections, Cytomegalovirus

Phase 1

The Safety and Effectiveness of Different Dose Levels of 1263W94 in the Treatment of Cytomegalovirus (CMV) of the Eyes in HIV-Infected Patients

CompletedNCT00002373

Glaxo WellcomeCytomegalovirus Infections, HIV Infections

Target: 56Updated: 2005-06-24

Study of SHP620 (Maribavir) in Healthy Adults

CompletedNCT02775240

ShireCytomegalovirus (CMV)

Start: 2016-07-21End: 2016-09-12Updated: 2021-06-03

A Study Comparing the Pharmacokinetics and Palatability of Two Candidate Pediatric Powder-for-Oral-Suspension Formulations of Maribavir to the Current Maribavir Tablet Formulation Administered in Healthy Adult Participants

TerminatedNCT04131556

ShireHealthy Volunteers

Start: 2019-10-25End: 2020-01-06Updated: 2025-09-02

Maribavir Food-Effect Study in Healthy Adults Participants

CompletedNCT05382104

TakedaHealthy Volunteers

Start: 2022-05-25End: 2022-07-02Updated: 2024-02-16

Phase 2

Maribavir for Prevention of CMV After Stem Cell Transplants

CompletedNCT00223925

ShireCytomegalovirus Infection

Start: 2004-10-28End: 2006-04-05Updated: 2021-05-13

Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients

CompletedNCT01611974

ShireCytomegalovirus (CMV)

Start: 2012-07-17End: 2014-12-05Updated: 2021-06-02

Phase II Trial of Maribavir for CMV in Patients With Lymphoid Malignancy on Bispecific Antibodies

RecruitingNCT07014319

Seoul National University HospitalCytomegalovirus (CMV)

Start: 2025-11-03End: 2028-01-31Target: 20Updated: 2025-12-04

Phase 3

Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients

CompletedNCT00411645

ShireCytomegalovirus Infections

Start: 2006-12-13End: 2009-05-23Updated: 2021-06-11

Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients

CompletedNCT00497796

ShireCytomegalovirus Infections

Start: 2007-07-23End: 2009-09-14Updated: 2021-06-11

A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants

CompletedNCT02927067

ShireCytomegalovirus (CMV)

Start: 2017-04-14End: 2022-07-01Updated: 2023-03-03

Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

CompletedNCT02931539

ShireCytomegalovirus (CMV)

Start: 2016-12-22End: 2020-08-17Updated: 2021-11-03

A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection

CompletedNCT05137717

TakedaCytomegalovirus (CMV)

Start: 2022-01-18End: 2023-06-27Updated: 2024-07-09

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)

RecruitingNCT05319353

TakedaCytomegalovirus (CMV)

Start: 2023-11-13End: 2027-01-18Target: 80Updated: 2025-07-17

"Full title (English): A Phase 3, open-label, single-arm, repeated-dose study to evaluate the safety and tolerability, pharmacokinetics, and antiviral activity of maribavir for the treatment of cytomegalovirus (CMV) infection in children and adolescents who have received a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT) "

Active, not recruitingCTIS2023-508988-73-00

Takeda Development Center Americas Inc.Cytomegalovirus (CMV) infection in children and adolescents who have received a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT)

Start: 2025-10-29Target: 21Updated: 2025-09-18

"Full title (English): A Phase 3, open-label, single-arm, repeated-dose study to evaluate the safety and tolerability, pharmacokinetics, and antiviral activity of maribavir for the treatment of cytomegalovirus (CMV) infection in children and adolescents who have received a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT) "

Active, not recruitingCTIS2023-508988-73-00

Takeda Development Center Americas Inc.Cytomegalovirus (CMV) infection in children and adolescents who have received a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT)

Start: 2025-10-29Target: 21Updated: 2025-09-18

A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections

RecruitingNCT06439342

TakedaCytomegalovirus (CMV)

Start: 2024-12-16End: 2026-12-31Target: 20Updated: 2026-03-02

Phase 4

Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients

CompletedNCT06034925

Medical University of South CarolinaCMV, Transplant Complication

Start: 2023-11-06End: 2025-08-30Updated: 2025-10-07

Unknown Phase

A Survey of Maribavir Tablets in Participants With Cytomegalovirus Infection

RecruitingNCT06577363

TakedaCytomegalovirus (CMV)

Start: 2024-08-28End: 2031-08-30Target: 250Updated: 2025-10-07

A Prospective Single-Arm Observational Study of Maribavir for the Treatment of Post Hematopoietic Stem Cell Transplantation Cytomegalovirus Infection

Not yet recruitingNCT07141095

Institute of Hematology & Blood Diseases Hospital, ChinaInfections, Cytomegalovirus

Start: 2025-09-25End: 2027-01-31Target: 17Updated: 2025-08-26

Related Papers

Association Between Cytomegalovirus Viremia Clearance and Post-Solid Organ Transplant Mortality in Patients With Refractory Cytomegalovirus Infection: SOLSTICE Post Hoc Analysis.

2025-11-26

Single-center retrospective analysis of maribavir in the treatment of refractory and drug-intolerant cytomegalovirus viremia and cytomegalovirus disease after allogeneic hematopoietic stem cell transplantation

Blood2025-11-03

A Randomized Controlled Trial Comparing the Tolerability and Efficacy of Maribavir vs. Valganciclovir for Cytomegalovirus (CMV) Prophylaxis in High-Risk Kidney Transplant Recipients: Study Protocol.

2025-08-27

Real-world effectiveness and tolerability of post solid organ transplant patients with CMV switching from valganciclovir treatment to maribavir: analysis using lab-linked claims data in the United States

Expert Review of Anti-infective Therapy2025-06-06

Maribavir for refractory cytomegalovirus infection (with or without resistance) in solid organ transplant recipients: Subgroup analysis of the phase 3 randomized SOLSTICE study

The Journal of Heart and Lung Transplantation2024-11-2812 citations

Comparative Emergence of Maribavir and Ganciclovir Resistance in a Randomized Phase 3 Clinical Trial for Treatment of Cytomegalovirus Infection

The Journal of Infectious Diseases2024-09-2020 citations

Cost‐effectiveness of maribavir versus conventional antiviral therapies for post‐transplant refractory cytomegalovirus infection with or without genotypic resistance: A US perspective

Journal of Medical Virology2024-04-018 citations

Maribavir: Mechanism of action, clinical, and translational science.

2024-01-0116 citations

Treatment for First Cytomegalovirus Infection Post–Hematopoietic Cell Transplant in the AURORA Trial: A Multicenter, Double-Blind, Randomized, Phase 3 Trial Comparing Maribavir With Valganciclovir

Clinical Infectious Diseases2023-11-2944 citations

S294: MARIBAVIR (MBV) VERSUS INVESTIGATOR-ASSIGNED THERAPY FOR REFRACTORY CYTOMEGALOVIRUS (CMV) INFECTION: SUBGROUPS ANALYSES OF PHASE 3 STUDY BY RESISTANCE STATUS KNOWLEDGE REPORTED BY INVESTIGATORS.

HemaSphere2023-08-01

Drug Resistance Assessed in a Phase 3 Clinical Trial of Maribavir Therapy for Refractory or Resistant Cytomegalovirus Infection in Transplant Recipients

The Journal of Infectious Diseases2023-07-2869 citations

Drug Resistance Mutations and Associated Phenotypes Detected in Clinical Trials of Maribavir for Treatment of Cytomegalovirus Infection.

2022-09-0160 citations

P16.38: Healthcare Resource Utilization in Transplant Recipients With Cytomegalovirus Infection Refractory to Prior Treatment With/Without Resistance Receiving Maribavir Versus Investigatorassigned Therapy: Exploratory Analysis of the Phase 3 SOLSTICE Trial

Transplantation2022-09-01

Maribavir for Refractory Cytomegalovirus Infections With or Without Resistance Post-Transplant: Results From a Phase 3 Randomized Clinical Trial

Clinical Infectious Diseases2021-12-01275 citations

21. Efficacy and Safety of Maribavir as a Rescue Treatment for Investigator Assigned Therapy in Transplant Recipients With Refractory or Resistant Cytomegalovirus Infections in the SOLSTICE Study: Phase 3 Trial Results

Open Forum Infectious Diseases2021-11-011 citations

Effects of Maribavir on P‐Glycoprotein and CYP2D6 in Healthy Volunteers

The Journal of Clinical Pharmacology2019-08-0611 citations

Maribavir for Refractory or Resistant Cytomegalovirus Infections in Hematopoietic-cell or Solid-organ Transplant Recipients: A Randomized, Dose-ranging, Double-blind, Phase 2 Study

Clinical Infectious Diseases2018-10-03212 citations

Maribavir for Treatment of Cytomegalovirus Infections Resistant or Refractory to Ganciclovir or Foscarnet in Hematopoietic Stem Cell Transplant or Solid Organ Transplant Recipients: A Randomized, Dose-Ranging, Double-Blind, Phase 2 Study

Biology of Blood and Marrow Transplantation2017-02-222 citations

Maribavir for Treatment of Cytomegalovirus (CMV) Infections Resistant or Refractory to Ganciclovir or Foscarnet in Hematopoietic Stem Cell Transplant (SCT) or Solid Organ Transplant (SOT) Recipients: A Randomized, Dose-Ranging, Double-Blind, Phase 2 Study

Open Forum Infectious Diseases2016-01-0110 citations

Fast selection of maribavir resistant cytomegalovirus in a bone marrow transplant recipient.

2013-07-1922 citations

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