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Tests treatment safety and results for Cytomegalovirus Infections
Official title Efficacy of Extended Letermovir Prophylaxis to Prevent CMV Reactivation in High-Risk Chinese Adults Undergoing Allogeneic HSCT
ClinicalTrials.gov ID: NCT06812598
What this study is testing
What is Letermovir (0-24w）?
Letermovir (0-24w） is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cytomegalovirus infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- After allogeneic hematopoietic stem cell transplantation (allo-HSCT), recipients are immunocompromised and at increased risk of complications, including cytomegalovirus (CMV) infection. International clinical guidelines for the management of CMV infection post-allo-HSCT recommend three main strategies: minimizing infection risk, prevention, and preemptive therapy.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The patients have decided to undergo an initial allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- The patients are ≥18 years old.
- The patients are CMV seropositive prior to transplantation.
- The patients have at least one high-risk factor for CMV reactivation, including: (1) Haploidentical transplantation, HLA-mismatched transplantation...
You likely can't join if
- Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Patients with evidence of CMV viremia at any time prior to enrollment.
- Patients with a history of CMV end-organ disease within 6 months prior to enrollment.
- Patients with suspected or known allergy to letermovir or any active or inactive components of similar drugs.
- Patients with severe hepatic impairment (defined as Child-Pugh Class C).
- Patients with end-stage renal disease with a creatinine clearance \< 10 mL/min.
See the full eligibility criteria
- The patients have decided to undergo an initial allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- The patients are ≥18 years old.
- The patients are CMV seropositive prior to transplantation.
- The patients have at least one high-risk factor for CMV reactivation, including: (1) Haploidentical transplantation, HLA-mismatched transplantation, or unrelated donor transplantation. (2) The primary source of stem...
- Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Patients with evidence of CMV viremia at any time prior to enrollment.
- Patients with a history of CMV end-organ disease within 6 months prior to enrollment.
- Patients with suspected or known allergy to letermovir or any active or inactive components of similar drugs.
- Patients with severe hepatic impairment (defined as Child-Pugh Class C).
- Patients with end-stage renal disease with a creatinine clearance \< 10 mL/min.
- Patients requiring mechanical ventilation or experiencing hemodynamic instability at the time of enrollment.
- Patients who received any investigational drug therapy within 28 days prior to enrollment.
- Patients who received or plan to receive any of the following treatments within 28 days prior to enrollment or during the study: cidofovir, CMV immune globulin, or any experimental CMV antiviral drugs/biological...
- Patients who previously participated or are currently participating in any study involving a CMV vaccine or other CMV investigational drugs, or who plan to participate in such studies during this trial.
- Patients who are pregnant or breastfeeding at the time of enrollment or planning to become pregnant within 90 days after the last dose of study medication.
- Patients who test positive for human immunodeficiency virus antibodies (HIV-Ab) at any time prior to randomization, or who test positive for hepatitis C virus antibodies (HCV-Ab) with detectable HCV RNA, or for...
- Patients with active solid malignancies, except for localized basal cell or squamous cell carcinoma of the skin or a condition currently under treatment (e.g., lymphoma).
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.