Comparing the Efficacy of Different Durations of Maribavir Treatment Regimens in Allo-HSCT
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
Ruijin Hospital
218 participants
Feb 28, 2026
INTERVENTIONAL
Conditions
Summary
To comparing the efficacy of different durations of Maribavir treatment regimens in patients suffering from refractory CMV infection after allo-HSCT.
Eligibility
Inclusion Criteria8
- First allogeneic hematopoietic stem cell transplantation;
- Age ≥ 18 years;
- 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;
- Provision of written informed consent and willingness to participate in this clinical study.
Exclusion Criteria8
- Known allergic constitution, particularly hypersensitivity to any component of maribavir;
- Active hepatitis B infection, defined as HBV DNA level ≥ 1 × 10³ IU/mL;
- Confirmed HIV infection;
- Severe impairment of major organ function, including but not limited to respiratory failure, cardiac failure, decompensated hepatic insufficiency, or renal insufficiency;
- Central nervous system CMV infection;
- History of substance use disorder or chronic alcoholism that may compromise the validity or interpretation of trial outcomes;
- Presence of a psychiatric disorder or cognitive impairment precluding the provision of informed consent;
- Any other condition deemed by the investigator to render the participant unsuitable for enrollment in this clinical trial.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07511127