Using Letermovir to Prevent CMV Infection After Stem Cell Transplant
Observational Clinical Study of Letermovir for Preventing CMV Infection After Allo-HSCT
This study is testing if the drug letermovir can help prevent CMV infections in patients who have just had a stem cell transplant, by looking at its safety and effectiveness based on their risk levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 14 Years to 100 Years |
| Sex | All |
| Sponsor | Zhengzhou University Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06306989 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect clinical data on the efficacy and safety of letermovir for preventing cytomegalovirus (CMV) infection in patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). Participants will be categorized into high-risk and intermediate-risk groups based on specific risk factors for CMV infection, with letermovir prophylaxis initiated at different times depending on their risk status. Blood samples will be monitored for CMV viremia using RT-qPCR until 100 days post-transplantation to assess the effectiveness of the treatment regimen.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 14 years and older who have undergone allo-HSCT and have positive CMV serology.
Not a fit: Patients with severe hepatic impairment, low creatinine clearance, or those currently receiving antiviral medications for CMV may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of CMV infections in patients after stem cell transplantation, improving their overall health outcomes.
How similar studies have performed: Other studies have shown promising results with letermovir for CMV prevention, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Biological age not less than 14 years. 2. Positive CMV serology. 3. No detectable CMV-DNA from plasma samples taken 5 days prior to randomization into groups. Exclusion Criteria: 1. severe hepatic impairment; 2. estimated creatinine clearance of less than 10 ml/min; 3. current or recent recipients of antiviral medications with anti-CMV activity; and 4. any other factor that affects the impact of obtaining data.
Where this trial is running
Zhengzhou, Henan
- Cao, Weijie — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Weijie Cao
- Email: 2549509184@qq.com
- Phone: +8618937390269
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.