๐ฌIn plain words
What the trial is, and whether it could suit you
To comparing the efficacy of different durations of Maribavir treatment regimens in patients suffering from refractory CMV infection after allo-HSCT.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. First allogeneic hematopoietic stem cell transplantation;
2. Age โฅ 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 โฅ2 weeks of appropriate antiviral therapy-specifically, CMV DNA levels remain unchanged (i.e., change โค logโโ) or increase (i.e., change \> logโโ)-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 โฅ 1 ร 10ยณ 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.