Comparing the Efficacy of Different Durations of Maribavir Treatment Regimens in Allo-HSCT
Recruiting now · Phase 3
Conditions studied: Hematologic Malignancy
In brief
To comparing the efficacy of different durations of Maribavir treatment regimens in patients suffering from refractory CMV infection after allo-HSCT.
Key facts
- Study ID
- NCT07511127
- Run by
- Ruijin Hospital
- People needed
- 218
- Starts
- 2026-02-28
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-04-06
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Ruijin Hospital, Shanghai JiaoTong University School of Medicine — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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