aplastic anemia
Conditions
Interventions
Treatment Group:Letermovir
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of SAA (meeting the Camitta criteria), with no available matched sibling donor, unsuitability for or refusal of allogeneic hematopoietic stem cell transplantation (Allo-HSCT), and opting to receive IST. 2. CMV-seropositive (CMV IgG-positive) with negative baseline CMV DNA (plasma =60 mL/min (calculated by the Cockcroft-Gault formula).
Exclusion criteria
Exclusion criteria: 1. Patients scheduled for HSCT or with a history of prior HSCT. 2. Patients with a history of hypersensitivity to the study drug or similar drugs. 3. Patients who are pregnant or lactating, or plan to become pregnant within 90 days after the last dose. 4. Receipt of any investigational drug therapy within 28 days prior to enrollment. 5. Evidence of CMV viremia at any time prior to enrollment. 6. History of CMV end-organ disease within 6 months prior to enrollment. 7. Receipt within 30 days prior to enrollment or planned use during the study of any of the following: cidofovir, CMV immunoglobulins, or any investigational CMV antiviral/biological therapy. 8. Severe hepatic impairment, defined as Child-Pugh Class C. 9. End-stage renal disease with creatinine clearance <10 mL/min. 10. Requiring mechanical ventilation or being hemodynamically unstable at enrollment. 11. Documented positive for human immunodeficiency virus antibody (HIV-Ab), evidence of active hepatitis C virus infection (detectable HCV RNA), or positive for hepatitis B surface antigen (HBsAg) within 90 days prior to enrollment. 12. Active solid malignancy, with the exception of localized basal cell or squamous cell skin cancer, or a malignancy under active treatment (e.g., lymphoma). 13. Prior or current participation in any study involving a CMV vaccine or other investigational CMV agent, or planned participation in such a study during the course of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of clinically significant CMV infection and CMV disease within 12 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events;Treatment response of SAA at 3 and 6 months; | — |
Countries
China
Contacts
Public ContactGuangsheng He
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed