New hope for transplant patients: shorter drug course may beat stubborn virus
NCT ID NCT07511127
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at the best length of treatment with the drug maribavir for a hard-to-treat CMV infection that can happen after a stem cell transplant. About 218 adults who have already had a transplant and have this infection will be randomly assigned to different treatment durations. The goal is to see which approach best prevents the infection from coming back.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 218 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ruijin Hospital, Shanghai JiaoTong University School of Medicine
RECRUITINGShanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Platelet-Boosting drug speed recovery after stem cell transplant?
- Can regional data improve bone marrow transplant results for blood cancers?
- Could a frailty score predict which older cancer patients survive intensive care?
- Why COVID-19 hits blood cancer patients harder: scientists map the immune clues
- Softer chemo before stem cell transplant aims to cure blood cancers in frail children
- Can a new drug stop the Body's attack after stem cell transplants?