Comparing the Efficacy of Different Durations of Maribavir Treatment Regimens in Allo-HSCT

March 31, 2026 updated by: Ruijin Hospital

Comparing the Efficacy of Different Durations of Maribavir Treatment Regimens in Patients With Refractory Cytomegalovirus Infection Following Allo-HSCT: a Prospective, Multicenter, Randomized, Controlled Clinical Trial

To comparing the efficacy of different durations of Maribavir treatment regimens in patients suffering from refractory CMV infection after allo-HSCT.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hematopoietic stem cell transplantation (HSCT) represents the only potentially curative modality for hematologic malignancies. Nevertheless, post-transplant infections substantially elevate the risk of transplant-related mortality, with cytomegalovirus (CMV) infection being among the most prevalent complications. Although advances in prophylactic strategies and preemptive antiviral therapy have contributed to a measurable reduction in both the incidence of CMV infection and CMV disease, refractory or drug-resistant (R/R) CMV infection following HSCT remains a significant global therapeutic challenge. Recent epidemiologic data indicate that the incidence of drug-resistant CMV infection in HSCT recipients ranges from 1.7% to 14.5%, while that of refractory CMV infection falls between 29% and 39%. Notably, in China, the incidence of refractory CMV infection after HSCT is slightly higher than the global average-approximately 47% . Therefore, the investigator conduct a multicenter, randomized, controlled study based on retrospective research to further explore the efficacy of different durations of Maribavir treatment regimens in Allo-HSCT.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
218

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. First allogeneic hematopoietic stem cell transplantation;
  2. Age ≥ 18 years;

  3. Confirmed refractory CMV infection;

    Refractory CMV infection is defined as fulfillment of any one of the following criteria:

    • Persistent or increasing CMV viremia despite ≥2 weeks of appropriate antiviral therapy-specifically, CMV DNA levels remain unchanged (i.e., change ≤ log₁₀) or increase (i.e., change > log₁₀)-concomitant with lack of clinical improvement or ongoing disease progression;
    • Drug-resistant CMV infection-defined as detection of specific CMV gene mutations associated with reduced susceptibility to one or more anti-CMV agents, in patients who otherwise meet the criteria for refractory CMV infection;
    • Intolerance to anti-CMV therapy-defined as inability to continue antiviral treatment due to severe adverse effects, such as clinically significant bone marrow suppression or renal impairment;
  4. Provision of written informed consent and willingness to participate in this clinical study.

Exclusion Criteria:

  1. Known allergic constitution, particularly hypersensitivity to any component of maribavir;
  2. Active hepatitis B infection, defined as HBV DNA level ≥ 1 × 10³ IU/mL;
  3. Confirmed HIV infection;
  4. Severe impairment of major organ function, including but not limited to respiratory failure, cardiac failure, decompensated hepatic insufficiency, or renal insufficiency;
  5. Central nervous system CMV infection;
  6. History of substance use disorder or chronic alcoholism that may compromise the validity or interpretation of trial outcomes;
  7. Presence of a psychiatric disorder or cognitive impairment precluding the provision of informed consent;
  8. Any other condition deemed by the investigator to render the participant unsuitable for enrollment in this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Fixed-duration group
The fixed-duration group that discontinued maribavir treatment after 8 weeks.
Drug: Maribavir
During the treatment period, maribavir is administered orally at a dosage of 400 mg twice daily. Participants will be stratified by clinical trial and received oral medication for varying durations.
Experimental: PCR-guided group
The experimental group discontinued maribavir after achieving two consecutive negative CMV-DNA PCR test, with a one-week interval, following drug administration.
Drug: Maribavir
During the treatment period, maribavir is administered orally at a dosage of 400 mg twice daily. Participants will be stratified by clinical trial and received oral medication for varying durations.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence of recurrent CMV infection
Time Frame: The primary endpoint is assessed 8 weeks after maribavir discontinuation following allo-HSCT
The incidence of recurrent CMV infection within 8 weeks after maribavir discontinuation
The primary endpoint is assessed 8 weeks after maribavir discontinuation following allo-HSCT

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of recurrent CMV infection
Time Frame: The secondary endpoint is assessed 16 weeks after maribavir discontinuation following allo-HSCT
The incidence of recurrent CMV infection within 16 weeks after maribavir discontinuation
The secondary endpoint is assessed 16 weeks after maribavir discontinuation following allo-HSCT
The incidence of recurrent CMV disease
Time Frame: Follow-up is conducted for 8 weeks following maribavir discontinuation.
The incidence of recurrent CMV disease within 8 weeks after maribavir discontinuation
Follow-up is conducted for 8 weeks following maribavir discontinuation.
CMV resistance mutations
Time Frame: Through study completion. It is expected within one year post-transplant.
The incidence of CMV resistance mutations
Through study completion. It is expected within one year post-transplant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RJBMT-2026CMV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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