Infections, CytomegalovirusNCT07141095
A Prospective Single-Arm Observational Study of Maribavir for the Treatment of Post Hematopoietic Stem Cell Transplantation Cytomegalovirus Infection
An observational study of Infections, Cytomegalovirus, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
The main aim of this study is to check the effectiveness and safety of maribavir for the treatment of CMV infection after HSCT in Chinese patients in real-world settings. The participants will be treated with maribavir for up to 8 weeks. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Infections, Cytomegalovirus
- What is being tested?
- maribavir
- Type of treatment
- Pill or oral medicine
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: Confirmed CMV infection, including CMV viremia and CMV disease after Hematopoietic Stem Cell Transplant.
Who may be able to join
- Hematopoietic Stem Cell Transplant Recipients
- Adult patients with an expected survival of ≥4 weeks.
- Confirmed CMV infection, including CMV viremia and CMV disease.
- Fully understand the content of the trial, voluntarily participate and complete the trial, and voluntarily sign the informed consent form.
Who cannot join
- Participants who meet any of the following criteria are not eligible for this study:
- Patients currently participating in other CMV-related clinical studies, such as those receiving anti-CMV drug treatment or involved in CMV vaccine clinical studies.
- At screening, liver function tests show: AST > 5×ULN, or ALT > 5×ULN, or total bilirubin ≥ 3.0×ULN.
- Patients with psychiatric disorders or severe psychological conditions that may affect the ability to provide informed consent or participate in follow-up consultations.
- Participants deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality
Erlie Jiang, +86-15122538106, jiangerlie@ihcmas.ac.cn
About this study
The main aim of this study is to check the effectiveness and safety of maribavir for the treatment of CMV infection after HSCT in Chinese patients in real-world settings.
The participants will be treated with maribavir for up to 8 weeks.
- Conditions
- Infections, Cytomegalovirus
- Being tested
- maribavir
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maribavirDrug
Maribavir tablets are administered orally at a dose of 0.4 g per administration (2 tablets of 0.2 g each), twice daily. The recommended duration of treatment is 8 weeks; however, the specific treatment duration should be individualized based on the clinical characteristics of each patient.
| Study group | Role | What they receive |
|---|---|---|
| Participants with CMV Infection | Participants will receive maribavirv tablets, 400 mg, orally twice a day(bid) for up to 8 weeks treatment period. Receives: Drug: maribavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV viremia clearance rate
The proportion of patients who had confirmed clearance of CMV viremia in plasma (defined as two consecutive CMV-DNA tests below the preemptive treatment threshold after treatment) after 4 weeks of treatment.
Measured: At Week 4
CMV disease remission rate
The proportion of patients who achieved remission of CMV disease after 4 weeks of treatment.
Measured: At Week 4
Secondary outcomes (4)
Number of participants with AEs
An AE was defined as any event emerging or manifesting at or after the initiation of treatment with a medicinal product or any existing event that worsened in either intensity or frequency following exposure to the medicinal product.
Measured: From first dose of study drug up to week 8
CMV DNA undetected time
The time when CMV DNA was first detected under the limit of detection in plasma.
Measured: From first dose of study drug up to week 8
CMV viremia clearance at the end of 8 weeks of treatment
The proportion of patients with confirmed clearance of CMV viremia in plasma at the end of 8 weeks of treatment.
Measured: At Week 8
Number of participants with all-cause mortality
All-cause mortality means death due to any cause.
Measured: From first dose of study drug up to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start25 Sep 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, CytomegalovirusStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141095
- Sponsor's protocol ID
- IIT2025003
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Arm Observational Study of Maribavir for the Treatment of Post Hematopoietic Stem Cell Transplantation Cytomegalovirus Infection
- ClinicalTrials.gov ID
- NCT07141095
- Acronym / sponsor ID
- IIT2025003
- Conditions
- Infections, Cytomegalovirus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 25 Sep 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to check the effectiveness and safety of maribavir for the treatment of CMV infection after HSCT in Chinese patients in real-world settings.
The participants will be treated with maribavir for up to 8 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with CMV Infection | – | Drug: maribavirParticipants will receive maribavirv tablets, 400 mg, orally twice a day(bid) for up to 8 weeks treatment period. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Confirmed CMV infection, including CMV viremia and CMV disease after Hematopoietic Stem Cell Transplant.
Key inclusion criteria (4 listed)
- Hematopoietic Stem Cell Transplant Recipients
Key exclusion criteria (5 listed)
- Participants who meet any of the following criteria are not eligible for this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maribavirMaribavir tablets are administered orally at a dose of 0.4 g per administration (2 tablets of 0.2 g each), twice daily. The recommended duration of treatment is 8 weeks; however, the specific treatment duration should be individualized based on the clinical characteristics of each patient. | Drug | Participants with CMV Infection |
Primary outcome
CMV viremia clearance rate
Time frame: At Week 4
The proportion of patients who had confirmed clearance of CMV viremia in plasma (defined as two consecutive CMV-DNA tests below the preemptive treatment threshold after treatment) after 4 weeks of treatment.
CMV disease remission rate
Time frame: At Week 4
The proportion of patients who achieved remission of CMV disease after 4 weeks of treatment.
4 secondary outcomes
Number of participants with AEs
Time frame: From first dose of study drug up to week 8
CMV DNA undetected time
Time frame: From first dose of study drug up to week 8
CMV viremia clearance at the end of 8 weeks of treatment
Time frame: At Week 8
Number of participants with all-cause mortality
Time frame: From first dose of study drug up to week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Cytomegalovirus, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiang Erlie, doctor (+86-15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV viremia clearance rate (time frame: At Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.