Clinical trial
Letermovir for the Prevention of Cytomegalovirus Infection in Hematopoietic Cell Transplant Recipients Based on the Outcome of Metagenomic Next-Generation Sequencing: a Phase 2, Open Label, Single-Arm Clinical Trial.
Name
mNGS+LMV
Description
Letermovir for the Prevention of CMV Infection in HSCT Recipients Based on the Outcome of mNGS
Trial arms
Trial start
2022-07-07
Estimated PCD
2024-07-01
Trial end
2025-09-01
Status
Recruiting
Phase
Early phase I
Treatment
Letermovir Pill
Letermovir is the world's first and only new drug approved for the prevention of CMV infection. In 2017, it was approved by the U.S. Food and Drug Administration (FDA) for the prevention of CMV infection and disease in CMV-seropositive adult recipients (R+) of allogeneic hematopoietic stem cell transplantation (allo-HSCT). It was approved in China on December 31, 2021.
Arms:
mNGS detection before stem cell transplantation
Other names:
Letermovir Tablets
Size
80
Primary endpoint
Incidence of clinically significant CMV infection with letermovir prevention after HSCT Defined as CMV DNAemia leading to preemptive treatment or presence of CMV disease
Time from registration to event, max 24 weeks
Eligibility criteria
Inclusion Criteria:
* HSCT candidate who has decided to primary transplant and is willing to participate in the study.
* HSCT candidate undergo mNGS detection before transplantation.
Exclusion Criteria:
* Patients below 14 years ago or above 65 years ago.
* Patients having active infection at the time of letermovir initiation.
* Patient recruited in a clinical study on an anti-CMV trial, or took similar anti-CMV drugs previously.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-09-01
1 organization