NCT07511127 Comparing the Efficacy of Different Durations of Maribavir Treatment Regimens in Allo-HSCT
| NCT ID | NCT07511127 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ruijin Hospital |
| Condition | Hematologic Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 218 participants |
| Start Date | 2026-02-28 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 218 participants in total. It began in 2026-02-28 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To comparing the efficacy of different durations of Maribavir treatment regimens in patients suffering from refractory CMV infection after allo-HSCT.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07511127 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07511127 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 218 participants.
Is NCT07511127 currently recruiting?
Yes, NCT07511127 is actively recruiting participants. Contact the research team at hxx12276@rjh.com.cn for enrollment information.
Where is the NCT07511127 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07511127 clinical trial?
NCT07511127 is sponsored by Ruijin Hospital. The trial plans to enroll 218 participants.